JP6604031B2 - Effect determination system and determination result storage method - Google Patents

Description

  The present invention relates to an effect determination system and a determination result storage method.

Pharmaceutical or medical device manufacturers, etc., request medical institutions to conduct clinical trials, so-called clinical trials, for confirming the effects of treatment with pharmaceuticals or medical devices.
Examinations for effect confirmation include examination imaging such as X-ray imaging (CR), X-ray tomography (CT), and nuclear magnetic resonance imaging (MRI). Examinations were taken before and after the trial, and how the size of the lesion in the medical image obtained by the examination after the trial began changed compared to the size before the trial. The doctor will observe and determine the effect of the treatment.

  When the number of subjects is large, the number of medical images obtained by examination imaging becomes enormous, and a clinical trial support system that can easily search for a desired medical image from a database has been developed (for example, Patent Document 1). reference.). According to this clinical trial support system, medical images can be displayed side by side in the order of examination photographing dates, and the burden on the doctor who makes the determination can be reduced.

Japanese Patent No. 4732233

Examination imaging after the start of the clinical trial is usually performed multiple times at intervals of 2 weeks, 4 weeks, etc. from the start of the clinical trial. Each time the examination imaging is performed, the doctor determines the effect of the treatment. ing. When a new lesion appears in a certain test image after the start of treatment, the determination may be performed a plurality of times for the once determined medical image, such as re-determination from the medical image before the start of the trial.
In preparation for an audit, it is necessary to save such past judgment results as a trail, but in the conventional clinical trial support system, judgment results are overwritten and saved every time a judgment is made. It was only the determination result, and the determination result on the way could not be saved.

  The subject of this invention is preserve | saving the log | history of the determination result of the effect of multiple times of treatment.

According to the invention of claim 1,
An effect determination system comprising a user terminal used by a doctor and a management server that manages information input in the user terminal,
The user terminal is
Display control means for displaying on the display means one or more series of medical images obtained by performing at least one examination imaging before and after the start of the clinical trial;
An operation means for receiving an input of a determination result of a treatment effect determined by a doctor according to the size of a lesion in each series of medical images before and after the start of the trial displayed on the display means;
Associating the determination result of the effect of the treatment with respect to each examination imaging before and after the start of the trial for which the input has been received by the operation means , with information associated with the number of determinations with respect to the examination imaging acquired from the management server Te, a transmission unit to be transmitted to the management server,
With
The management server is
The medical image requested from the user terminal is transmitted to the user terminal, and based on the transmission of the medical image, the number of determinations for examination imaging related to the medical image is counted.
Storage means for storing the number of determinations for each inspection image in association with information associated with the number of determinations;
On the basis of the information associated with the number of determinations that have been transmitted from the user terminal, and the determination result of the effect of the transmitted said treatment from said user terminal, against the test shooting according to the determination result of the effect of the therapeutic determine in association with a constant number of times, and a control means for storing in said memory means,
There is provided an effect determination system characterized by comprising:

According to invention of Claim 2,
The operation means receives an input of a determination result of the size of one or a plurality of lesions in the medical image determined by a doctor together with the effect of the treatment,
The transmission unit, the size of the determination result of the determination result of the therapeutic effect of accepting the input and the one or more lesions by the operation means, in association with the number of determinations and associated information, wherein To the management server,
The control means , based on the information associated with the determination count transmitted from the user terminal, the determination result of the treatment effect transmitted from the user terminal and the size of the one or more lesions the determination result in association with the previous SL-size constant number, the effect determination system according to claim 1, characterized in that to be stored in said storage means.

According to invention of Claim 3,
The operation means accepts an input of a determination result of a position of one or a plurality of lesions in the medical image determined by a doctor together with the effect of the treatment,
The transmission unit associates the determination result of the effect of the treatment received the input by the operation unit and the determination result of the position of the one or more lesions with the information associated with the determination count, and the management To the server,
The control means determines the determination result of the effect of the treatment transmitted from the user terminal and the positions of the one or more lesions based on information associated with the determination count transmitted from the user terminal. the results, in association with pre-Symbol-size constant number, the effect determination system according to claim 1 or 2, characterized in that stored in the storage means.

According to invention of Claim 4,
The operation means receives an input of the name of one or a plurality of lesions in each series of medical images before the start of the trial, and uses the received names in the medical images of each series after the start of the trial. Accepts the input of one or more lesion names
The transmission means transmits the names of one or more lesions received by the operation means to the management server,
The control means associates the lesion part that has received the input of the same name among one or a plurality of lesion parts that have received the input of the name by the operation means between the examination imaging before and after the start of the trial. Then, the name of each received lesion is stored in the storage means, and the effect determination system according to claim 2 or 3, is provided.

According to the invention of claim 5,
It said operating means, of the trial before the start start after multiple determine the constant result of acceptance of each test shooting, receives an input of determination count determination result to be displayed,
Wherein the display control unit, among the plurality of determination results, according to the determination result of the determination count the input of which is accepted by the operation means by obtaining from said storage means, characterized in that that presents on the display means Item 4. The effect determination system according to Item 4, is provided.

According to the invention of claim 6,
Wherein the display control unit, and determine the constant results of a plurality of times for testing imaging before the start of the trial, among the plurality of determine the constant result for test shooting after the start of the trial, lesions of the same name is associated with 6. The effect determination system according to claim 5, wherein the determination result of the determined number of times is acquired from the storage unit and displayed on the display unit .

According to the invention of claim 7,
A determination result storage method executed by an effect determination system comprising a user terminal used by a doctor and a management server that manages information input in the user terminal,
The display control means of the user terminal causes the display means to display one or more series of medical images obtained by performing at least one examination imaging before and after the start of the trial;
According to the size of the lesion in each series of medical images before and after the start of the trial displayed on the display means, the input of the determination result of the treatment effect determined by the doctor is input to the user terminal. Steps received by the operating means;
The number of determinations for the examination imaging obtained from the management server for the results of the determination of the effect of the treatment on each examination imaging before and after the start of the clinical trial that was received by the operation means by the transmission means of the user terminal Associating with the information associated with and transmitting to the management server;
Transmitting the medical image requested from the user terminal to the user terminal by the control means of the management server, and counting the number of determinations for examination imaging related to the medical image based on the transmission of the medical image;
Correspondence between the number of determinations for each examination image stored in the storage unit of the management server and the information associated with the number of determinations by the control unit of the management server, and the determination transmitted from the user terminal based on the information associated with the number, associates the determination result of the effect of the transmitted said treatment from said user terminal, and determine the constant number against the test shooting according to the determination result of the effect of the treatment, the Storing in the storage means;
A determination result storing method characterized by including: is provided.

  According to the present invention, it is possible to store a history of determination results of a plurality of treatment effects.

It is a figure which shows the structural example of the effect determination system of embodiment of this invention. It is a block diagram which shows the structure of a user terminal for every function. It is a figure which illustrates the network environment of an effect determination system. It is a figure which shows the imaging | photography timing of each test | inspection imaging implemented at the time of clinical trial, and several series of medical images obtained by each test | inspection imaging | photography. It is a figure which shows an example of the management table of medical images. It is a figure which shows an example of the management table of a determination result. It is a flowchart which shows the process sequence of the effect determination system at the time of determination with respect to the test | inspection imaging | photography (baseline) before a clinical trial start. It is a figure which shows an example of the table of the determination result with respect to the test | inspection imaging | photography before a clinical trial start. It is a figure which shows an example of the operation screen which can display a medical image and can input a determination result. It is a figure which shows an example of the dialog screen which can edit the name of a lesioned part. It is a flowchart which shows the process sequence of the effect determination system at the time of determination with respect to the test | inspection imaging | photography (VISITx) after a clinical trial start. It is a figure which shows an example of the dialog screen which can match the lesioned part in the medical image obtained by the test | inspection imaging | photography after a clinical trial start with the lesioned part in the medical image obtained by the test | inspection imaging | photography before the clinical trial start. (A) It is a figure which shows the medical image before a lesioned part isolate | separates or unites. (B) It is a figure which shows the medical image after a lesion part isolate | separated. (C) It is a figure which shows the medical image after a lesion part united. It is a figure which shows an example of the table of the determination result with respect to the test | inspection imaging | photography after a clinical trial start when a lesion part isolate | separates and a new lesion part is detected. It is a figure which shows an example of the table of the determination result with respect to the test | inspection imaging | photography after a clinical trial start when a lesioned part united. (A) It is a figure which shows the determination result of the 1st time of the position and magnitude | size of a lesioned part in a medical image. (B) It is a figure which shows the determination result of the 2nd time of the position and size of a lesioned part in a medical image. (C) It is a figure which shows the determination result of the 3rd time of the position and magnitude | size of a lesioned part in a medical image. It is a figure which shows the correspondence of the lesioned part in the medical image obtained by each test | inspection imaging | photography before the trial start and after the trial start. It is a figure which shows an example of the display screen of the determination result with respect to each test | inspection imaging | photography before the trial start and after the trial start. It is a figure which shows the correspondence of the lesion part of the determination result of the determination frequency | count 2 with respect to the test | inspection imaging | photography before a clinical trial start, and the determination result of the determination frequency | count of 1 with respect to the 2nd test | inspection imaging | photography after a clinical trial start displayed with the said determination result. It is a figure which shows the correspondence of the lesion part of the determination result of the determination frequency | count 2 with respect to the test | inspection imaging | photography before a clinical trial start, and the determination result of the determination frequency | count of 3 with respect to the 1st test | inspection imaging | photography after a clinical trial start displayed with the said determination result. It is a figure which shows the correspondence of the determination result preserve | saved by the conventional method.

  Embodiments of an effect determination system and a determination result storage method according to the present invention will be described below with reference to the drawings.

FIG. 1 shows an example of the configuration of an effect determination system 1 according to an embodiment of the present invention.
The effect determination system 1 is a system for supporting the work of a doctor (hereinafter also referred to as a determining doctor) who observes a medical image obtained by examination imaging and determines the effect of a clinical trial. Display, and input and save the results of the clinical trial results.

As shown in FIG. 1, the effect determination system 1 includes a plurality of user terminals 10 used by a determining doctor for observation of medical images, input of determination results of clinical trial effects, and transfer of medical images to each user terminal 10. And a management server 20 for managing the determination result input in each user terminal 10.
Each user terminal 10 and the management server 20 can communicate with each other via a network N1 such as an intranet.

FIG. 2 shows the configuration of the user terminal 10 for each function.
As illustrated in FIG. 2, the user terminal 10 includes a control unit 11, a storage unit 12, a communication unit 13, an operation unit 14, and a display unit 15.

The control unit 11 includes a CPU (Central Processing Unit), a RAM (Random Access Memory), and the like. The control unit 11 reads the program stored in the storage unit 12 and executes various processes.
For example, the control unit 11 causes the communication unit 13 to acquire one or more series of medical images obtained by the examination imaging before and after the start of the clinical trial from the management server 20, and the acquired medical images are displayed by the display unit 15. Display. In addition, the control unit 11 causes the operation unit 14 to receive a plurality of determination results of the effect of treatment, and causes the storage unit 12 to store all of the received determination results of the plurality of times. The control unit 11 can also store in the storage unit 12 the determination results, names, and the like of the size and position of one or more lesions in the medical image that have been input together with the determination result of the treatment effect by the operation unit 14. it can. Further, the control unit 11 causes the communication unit 13 to transmit the determination result stored in the storage unit 12 to the management server 20.

The storage unit 12 stores a program that can be read by the control unit 11, data used when the program is executed, and the like. As the storage unit 12, a large-capacity memory such as a hard disk can be used.
The storage unit 12 stores the determination result of the effect of one or more treatments, the determination result of the size and position of one or more lesions in the medical image, the name, and the like.

  The communication unit 13 communicates with other user terminals 10 or the management server 20 on the network N1 according to a communication protocol.

  The operation unit 14 determines the effect of the treatment determined by the determining physician according to the size of one or a plurality of lesions in each series of medical images before and after the start of the clinical trial, and 1 in the medical image. Alternatively, an input of determination results of positions and sizes of a plurality of lesions is accepted. As the operation unit 14, a keyboard, a mouse, or the like can be used.

  The display unit 15 displays a medical image of each series before and after the start of the clinical trial, an operation screen on which the determination result of the treatment effect can be input, and the like according to the display control of the control unit 11. As the display unit 15, an LCD (Liquid Crystal Display), an OELD (Organic Electro Luminescence Display), a touch panel configured integrally with the operation unit 14, or the like can be used.

The management server 20 acquires one or a plurality of series of medical images obtained by each examination imaging before and after the start of the clinical trial from the image management system of the medical institution and transmits them to the user terminal 10. In addition, the management server 20 receives and stores the determination result of the treatment effect from each user terminal 10.
The configuration of the management server 20 is basically the same as that of the user terminal 10, and includes the control unit 11, the storage unit 12, the communication unit 13, the operation unit 14, the display unit 15 and the like shown in FIG. Yes.

  As shown in FIG. 3, the effect determination system 1 performs or supports a clinical trial management system A1 and an image management system A2 used by a medical institution, a clinical trial requester, and clinical trial work via a network N2 such as the Internet. It is possible to communicate with a clinical trial implementation system C used by a Contract Research Organization (CRO). The network N2 is preferably a VPN (Virtual Private Network) or the like in order to protect privacy and prevent information leakage.

The flow of clinical trial will be described below.
First, a clinical trial implementation plan is prepared between the clinical trial sponsor and the CRO, and the clinical trial contents such as a medical institution conducting the clinical trial, a medication schedule, a dosage, a type of examination imaging, and an interval are determined.
The CRO inputs the contents of the clinical trial to the clinical trial implementation system C and registers the implementation of the clinical trial. The clinical trial implementation system C creates trial request information according to the registered contents and transmits it to the clinical trial management system A1 of the medical institution.

Next, a medical institution prepares a schedule for examination imaging, and receives approval from the clinical trial sponsor regarding the suitability of the imaging apparatus.
The medical institution confirms the request information for conducting the clinical trial using the clinical trial management system A1, and determines the imaging device used for examination imaging, the scheduled imaging date, and the like. The medical institution inputs a decision item to the clinical trial management system A1 and registers the trial implementation schedule. The clinical trial management system A1 creates notification information scheduled to be executed according to the registered contents and transmits it to the clinical trial execution system C.
The clinical trial requester confirms the notification information of the clinical trial implementation schedule by the clinical trial implementation system C, and inputs to the clinical trial implementation system C whether or not the imaging apparatus used for the clinical trial is suitable for the clinical trial. The clinical trial implementation system C creates notification information of conformity or nonconformity of the imaging apparatus according to the input content, and transmits it to the clinical trial management system A1.

Once the sponsor is approved for the suitability of the imaging device, the medical institution performs medication for the trial, examination imaging, etc.
Upon confirming the notification information of the conformity of the imaging apparatus, the clinical trial management system A1 creates examination radiographing order information according to the registered contents of the clinical trial implementation schedule and transmits it to the image management system A2. The medical institution confirms the schedule of the clinical trial by the clinical trial management system A1, confirms the order information of the examination imaging by the image management system A2, and implements medication, examination imaging, and the like.
In addition, when the notification information on the non-conformance of the photographing apparatus is confirmed, the medical institution repeats re-registration of the photographing apparatus to be used until the notification information on the conformity of the photographing apparatus is obtained.

The image management system A2 is generally referred to as PACS (Picture Archiving and Communication System), and in accordance with DICOM (Digital Imaging and Communication in Medicine), generation, storage, and storage of medical images by imaging apparatuses such as CR, CT, MRI, Perform forwarding, etc.
When a medical image is generated in each imaging apparatus by performing the examination imaging, the image management system A2 performs imaging such as the series ID, image ID, file name, imaging apparatus, and imaging date of the medical image to the clinical trial management system A1. Information is generated and transmitted, and medical images are registered.

Each time examination imaging is performed, the judging doctor observes the medical image and judges the effect of the treatment.
The clinical trial management system A1 transmits the registered medical image from the image management system A2 to the clinical trial execution system C. The CRO confirms the registered medical images and imaging conditions by the clinical trial implementation system C, and performs registration to approve that the medical images are appropriate medical images that comply with the clinical trial implementation plan. This confirmation work is called QC (Quality Control). When registration of approval for medical images is performed, the clinical trial implementation system C transmits notification information for approval of medical images to the clinical trial management system A1, and registers a determination request.

In response to the registration of the determination request, the clinical trial management system A1 transmits information on the clinical trial and the subject, imaging execution information, etc. to the effect determination system 1 as determination request information, and transfers the medical image in which the determination request is registered. Is generated and transmitted to the image management system A2. The image management system A2 transfers the medical image to the effect determination system 1 in accordance with the transfer instruction information.
The determination doctor who determines the effect of the clinical trial based on the medical image confirms the determination request information by the effect determination system 1, and performs the determination by displaying the medical image transferred from the image management system A2. The effect determination system 1 accepts and stores the input of the determination result of the effect of the treatment by the determining doctor.

When all examination imaging and its determination are completed, the effect determination system 1 transmits the stored determination result to the clinical trial execution system C.
The CRO confirms the determination result by the clinical trial execution system C, creates a case report based on the determination result, and registers it in the clinical trial execution system C. The clinical trial requester can confirm the case report by the clinical trial implementation system C.

  In a medical institution, before and after the start of a clinical trial, that is, before and after using a medicine or a medical device for a subject, examination imaging is performed with one or a plurality of imaging apparatuses registered in advance. The number of times of examination imaging before the start of the clinical trial is normally one, but after the clinical trial is started, multiple imaging examinations are performed at intervals of, for example, two weeks, four weeks, and the like. The interval between examination shots is determined according to the clinical trial plan.

Since each examination radiographing is performed at each visit of the subject, it is called VISIT. Generally, the examination radiographing performed at the timing before the start of the clinical trial is performed before the start of the drug, and after the start of the clinical trial, there are a plurality of intervals. Test imaging performed at the timing is called VISIT after medication. VISIT before medication is sometimes referred to as a baseline because it is a criterion for determining the size of a lesion. Further, post-dose VISIT performed at a plurality of timings is combined with the elapsed time from the administration, for example, test imaging performed at the timing of 2 weeks and 4 weeks after the administration is 2 weeks after VISIT and 4 weeks after VISIT, respectively. May be distinguished.
Hereinafter, the pre-dose VISIT is referred to as a baseline, and the post-dose VISIT performed at a plurality of timings is represented as VISITx in combination with a number x representing the number of imaging after the start of the trial. For example, VISIT1 represents the first VISIT after the start of the trial, and VISIT2 represents the second VISIT after the start of the trial.

  In the baseline and VISITx, the same imaging region is imaged using the same imaging device. The medical image obtained by each examination imaging of the baseline and VISITx is a series of medical images in which each imaging apparatus is one unit, or even in the same imaging apparatus, each imaging region is one unit. For example, hundreds of medical images generated by one imaging by CT may be generated as one series of medical images, or one medical image generated by CR may be used as one series of medical images. It may be generated as an image.

FIG. 4 shows an example of a medical image obtained by each examination imaging of the baseline and VISITx.
As shown in FIG. 4, the baseline imaging timing is 2 weeks before the start of medication, and the imaging timing of VISIT 1 and 2 is 2 weeks and 4 weeks after the initiation of medication, respectively.
As shown in FIG. 4, in the baseline, three imaging parts are imaged by CT to generate three series of medical images Gc1, Gc2, and Gc3, and two imaging parts are imaged by MRI. Medical images Gm1 and Gm2 are generated. Similarly, in VISIT 1 and 2, three series of medical images Gc4 to Gc6 and Gc7 to Gc9 are generated by CT, and two series of medical images Gm3 and Gm4, and Gm5 and Gm6 are respectively generated by MRI. A series ID is assigned to each series of medical images to identify each series, and an image ID is also assigned to each medical image forming one series.

As described above, one or a plurality of series of medical images generated by the baseline and VISITx are provided from the image management system A2 to the effect determination system 1 after the approval of the CRO.
In the effect determination system 1, the management server 20 obtains necessary information from the clinical trial management system A1 every time a clinical trial baseline or VISITx medical image is obtained from the image management system A2, and the medical image management table. Create

FIG. 5 shows an example of a medical image management table.
As shown in FIG. 5, the medical image management table is generated by the clinical trial ID, the VISIT ID, the baseline and the VISITx examination imaging date, the imaging device used, the imaging site, and each imaging device. Includes items such as the number of series of medical images and the series ID of each series. The clinical trial ID is identification information assigned for each clinical trial. The VISIT ID is identification information assigned to each examination imaging of the baseline and VISITx.

  The medical image management table shown in FIG. 5 indicates that, for example, the baseline examination date of the trial ID is XX01 and the VISIT ID is BL0 is January 26, 2014, and the imaging apparatus is CT and MRI. Yes. In addition, three series of medical images with the abdomen taken as an imaging region are generated by CT, and the series IDs are C1, C2, and C3, respectively.

The management server 20 creates a list of medical images to be determined based on the created medical image management table, and transmits the list to each user terminal 10.
Each user terminal 10 has a baseline of a trial in which a judgment is made from a plurality of trials based on a list acquired from the management server 20 when a judgment start operation is performed by a judgment doctor who has logged into the user terminal 10. Alternatively, an operation screen for selecting VISITx is displayed.
Each user terminal 10 requests the management server 20 for a baseline or VISITx medical image selected by the determining doctor on this operation screen. When the requested medical image is transmitted from the management server 20, the user terminal 10 displays the medical image and accepts the input of the determination result by the determining doctor.

  The management server 20 creates a management table of determination results for each examination imaging of the baseline or VISITx each time a clinical image of each trial or VISITx is transmitted to the user terminal 10.

FIG. 6 shows an example of a management table of determination results.
As shown in FIG. 6, the determination result management table includes items such as clinical trial ID, VISIT ID, determination frequency n, determination result ID, and determination date. The determination result ID is identification information assigned to a determination result for each of the baseline and VISITx inspection imaging of the determination number n.
In the management table of determination results shown in FIG. 6, for example, the first determination (determination number n = 1) for the examination examination of the baseline with the trial ID XX01 and the VISIT ID BL0 is performed on February 1, 2014. It shows that the determination result ID of the determination result is BL0-1.

FIG. 7 shows a processing procedure at the time of determination with respect to the baseline in the effect determination system 1.
In the effect determination system 1, the user terminal 10 requests a baseline medical image from the management server 20. The management server 20 transmits the baseline medical image to the user terminal 10.
As shown in FIG. 7, the management server 20 that has transmitted the medical image counts the number n of determinations of the current baseline determination (step S1). Further, the management server 20 assigns a new determination result ID, associates the determination number n and the determination result ID with the baseline clinical trial ID and VISIT ID, respectively, in the determination result management table (see FIG. 6). Write.

On the other hand, the user terminal 10 that has received the medical image newly creates a baseline determination result table, and acquires and writes the determination result ID assigned by the management server 20.
FIG. 8 shows an example of a table of baseline determination results.
As shown in FIG. 8, the baseline determination result table includes a determination result ID, a lesion part ID, a lesion part name, a type, a site, a lesion part position determination result, a lesion part size determination result, Includes items such as assessment of target lesions or non-target lesions. Details of each item will be described later.

The user terminal 10 displays an operation screen on which the position and size determination result of the lesioned part, the determination result of the clinical trial effect, and the like can be input by the display unit 15, and the acquired baseline medical image is displayed on the operation screen. (Step S2).
The user terminal 10 can perform stack display in which one series of medical images is arranged in the entire display area, or can be tiled display in which a plurality of series of medical images are arranged in a plurality of divided areas by dividing the display area. Is possible. In any display style, when one series includes a plurality of medical images with different slice positions, all the medical images can be displayed by sequentially switching the slice positions.

FIG. 9 shows an example of the operation screen.
As shown in FIG. 9, the display style of the operation screen d1 is tile display, and the user terminal 10 displays four series of medical images in four divided areas of the display area, respectively. Of the four series, three series are series obtained by CT, and the user terminal 10 displays a medical image with the first slice position in the display area of each series during initial display. The user terminal 10 can sequentially switch to and display the medical image at the next slice position in accordance with the slice position switching operation of the judging doctor in the display area of each series.

The determining doctor can perform an operation for measuring the size of a lesioned part in a medical image, an operation for editing the name of a lesioned part, and the like on the operation screen d1 using the operation unit 14.
For example, the user terminal 10 receives a selection input in the pull-down menu d13 shown in FIG. 9, and displays a ruler annotation d11 on the operation screen d1. The judging doctor arranges the ruler annotation d11 at the position of the lesion part classified as a measurable lesion in the medical image and expands or contracts the length of the ruler annotation d11 according to the size of the lesion part. It can be carried out. The measurable lesion is a classification of a lesion that can be measured in a size defined in a judgment rule called a guideline, and a lesion that is not classified as a measurable lesion is classified as a non-measurable lesion.

  Similarly, the user terminal 10 receives a selection input in the pull-down menu d13 and displays an arrow annotation d12 on the operation screen d1. The judgment doctor can perform an operation of arranging the arrow annotation d12 so as to indicate the position of the lesion part or the like where the size of the lesion part is small and it is difficult to measure the size.

When the determination doctor performs an operation of arranging the annotations d11 and d12 (step S3: Y), the user terminal 10 displays a dialog screen for editing the names of the lesions where the annotations d11 and d12 are arranged.
FIG. 10 shows an example of a dialog screen.
As shown in FIG. 10, the dialog screen d2 is provided with an input field d21 for selecting a lymph node or a non-lymph node, and an input field d22 of an arbitrary name. In the case of a lymph node, it is possible to input a fixed sentence for the lymph node, and an input field d23 for selecting a fixed sentence for the lymph node part and an input field d24 for selecting a fixed sentence for the name of the lymph node are provided.

When the user terminal 10 receives an input of the name of the lesioned part, the type of lesion, the region, and the like by the determining doctor on the dialog screen d2 through the operation unit 14, the user terminal 10 bases the received name of the lesioned part in association with the determination result ID. Write to the line result table. For example, when a lymph node is selected in the input field d21, the user terminal 10 can use the fixed sentence of the name selected in the input fields d23 and d24 as the name of the lesion. When a non-lymph node is selected in the input field d21, the user terminal 10 can set an arbitrary name input in the input field d22 as the name of the lesion.
In addition, the user terminal 10 assigns a new lesion ID to the name of the lesion by the control unit 11, writes it in the baseline determination result table (see FIG. 8), and saves it in the storage unit 12 (step). S4).

  The user terminal 10 uses the control unit 11 to identify the series ID of the medical image in which the annotation d11 or d12 is arranged, the slice position in the series, and the position in the medical image, and determine the position of the lesion determined by the determining doctor As a result, the result is written in the baseline determination result table (see FIG. 8) in association with the lesion ID.

Slice positions in a series of medical images can be represented in the order in which one series of medical images is arranged in the order of slice positions. For example, the 255/496 slice position shown in FIG. 8 indicates that one series is composed of medical images at the first to 496th slice positions, of which the 255th slice position.
When the ruler annotation d11 shown in FIG. 9 is used, the position of the lesion in the medical image can be represented by the coordinates (x, y) of the pixel located at the center in the length direction of the ruler. When the arrow annotation d12 shown is used, it can be represented by the coordinates (x, y) of the pixel located at the tip of the arrow. The coordinates (x, y) are coordinates when the positions of the pixels arranged in a two-dimensional manner are expressed in xy coordinates.

  When the ruler annotation d11 is arranged, the user terminal 10 measures the length of the ruler annotation d11 by the control unit 11, and displays the measured value near the annotation d11 by the display unit 15. In addition, the control unit 11 writes the measurement value as a determination result of the size of the lesioned part by the determining physician in association with the lesioned part ID in a baseline determination result table (see FIG. 8) and stores it in the storage unit 12. Save (step S5).

Examples of the size of a lesion part to be measured include a major axis, a minor axis, and a sum of diameters of the lesion part.
The major axis and minor axis of the lesioned part are the maximum length and the minimum length in the area of the lesioned part, respectively. The sum of the diameters of the lesions is the sum of the major and minor diameters of all target lesions. Since the object to be measured differs depending on the type of lesion, such as the long diameter for non-lymph nodes and the short diameter for lymph nodes, the size according to the guidelines may be measured.
Note that the major axis, minor axis, sum of diameters, and the like of the lesion are examples of the determination result of the size of the lesion. If the size of the lesion can be determined, the present invention is not limited to this. For example, the determining doctor performs an operation for specifying the range of the lesion, and measures the area (number of pixels) of the specified region. Also good.

  The judging doctor sequentially observes the medical images of each series in the baseline, and detects a lesion in each medical image. Until the determination doctor performs an operation for ending the detection of all lesions (step S6; N), the user terminal 10 performs the above-described lesion site name, position, and position every time the annotation d11 or d12 is placed. The receiving of the input of the size determination result and the saving of the created baseline determination result in the table are repeated (steps S3 to S5).

When the determination doctor performs an operation for ending the detection of the lesioned part (step S6: Y), the user terminal 10 displays a list of the names of the respective lesioned parts stored in the determination result table by the display unit 15, and each lesioned part is displayed. An operation screen that allows selection of target lesion or non-target lesion evaluation is displayed. The target lesion is a predetermined number, for example, five lesions selected in descending order of diameter among measurable lesions. A non-target lesion is a lesion that has not been selected as a target lesion. The number selected as the target lesion will conform to the guidelines.
In response to the selection operation accepted by the operation unit 14, the user terminal 10 writes the evaluation of whether the lesion is a target lesion or a non-target lesion in the baseline determination result table by the control unit 11 and saves it in the storage unit 12. (Step S7).

  After saving the evaluation of the target lesion or the non-target lesion, the user terminal 10 transmits a table of baseline determination results to the management server 20. The management server 20 stores the received baseline determination result table, writes the received date as a determination date in the determination result management table (see FIG. 8), and stores it (step S8). The determination result table and the determination result management table are associated with each other by the determination result ID, and the determination result management table is associated with the determination result ID and the determination count n. n can be stored as a determination result.

  After the baseline is determined, when a medical image is generated by VISITx and the determination is requested, the determining doctor makes a determination on VISITx. At the time of determination with respect to VISITx, the determining physician detects the same lesion as the baseline from the medical image of VISITx, observes the change in size thereof, and detects a newly appearing lesion.

FIG. 11 shows a processing procedure when determining VISITx in the effect determination system 1.
In the effect determination system 1, when a determination doctor who logs in to the user terminal 10 performs a determination start operation on VISITx, the user terminal 10 requests a medical image of VISITx from the management server 20. The management server 20 transmits a VISITx medical image to the user terminal 10.

As shown in FIG. 11, the management server 20 that has transmitted the medical image counts the determination number n of the current VISITx determination (step S11). Further, the management server 20 assigns a new determination result ID, and writes the determination number n and the determination result ID in association with the clinical trial ID and VISIT ID of VISITx in the determination result management table (see FIG. 6).
On the other hand, the user terminal 10 creates a new VISITx determination result table by the control unit 11 and acquires and writes the determination result ID assigned by the management server 20. The table of determination results of VISITx has the same configuration as the table of determination results of baseline except that it has an item of determination results of therapeutic effects.

The user terminal 10 causes the display unit 15 to display the acquired VISITx medical image on the operation screen d1 shown in FIG. 9 (step S12).
When the user terminal 10 receives an operation for arranging the annotation d11 or d12 in the medical image displayed on the operation screen d1 by the operation unit 14 (step S13: Y), the user terminal 10 selects the name of the lesion part where the annotation d11 or d12 is arranged. Display the dialog screen for editing.
FIG. 12 shows an example of the dialog screen.
As shown in FIG. 12, the dialog screen d3 displays an input field d31 in which it is possible to select whether to use the same name as the baseline or a new name as the name of the lesion where the annotation d11 is placed. ing.

In the input field d31, when it is selected to use the same name as the baseline (step S14: Y), the user terminal 10 uses the communication unit 13 to store the name of the lesion part stored as the baseline determination result, The management server 20 is requested for the lesion ID and the like.
The management server 20 acquires the determination result ID of the baseline having the same clinical trial ID as VISITx being determined in the user terminal 10 from the determination result management table, and from the baseline determination result table corresponding to the acquired determination result ID. One or a plurality of lesion names, lesion IDs, and the like are acquired and transmitted to the user terminal 10. When there are a plurality of determination results, the management server 20 obtains a table of the maximum determination number, that is, the last determination result.
As shown in FIG. 12, the user terminal 10 causes the display unit 15 to display an input field d32 in which the name of the acquired lesion site can be selected and input on the dialog screen d3. Further, the user terminal 10 displays, on the display unit 15, an input field d33 for evaluating a target lesion or a non-target lesion and an input field d34 for evaluating a measurable lesion or an unmeasurable lesion, for each acquired name of the lesion. It is displayed on the dialog screen d3.

  When the selection input of the name of any lesion in the input field d32 is received by the operation unit 14, the user terminal 10 is the same as the baseline in which the selection input is received by the control unit 11 in the determination result table of VISITx. The lesion name, lesion ID, lesion type, and site are written and stored in the storage unit 12 (step S15). By assigning the same lesion ID as the baseline lesion to the lesion of VISITx, it is possible to associate each lesion as the same lesion whose size is compared between the baseline and VISITx.

When the lesion part of the baseline is separated or fused over time, by selecting the same name as the name of the lesion part of the baseline before separation or fusion on the dialog screen d3 shown in FIG. It is possible to associate the lesion area of the baseline with the lesion area of VISITx after separation or fusion.
For example, as shown in FIG. 13 (a), one lesion g1 to which the name of the renal lymph node is given in the baseline is converted into two lesions g11 and g12 in VISIT1 as shown in FIG. 13 (b). When separated into two, the names of the same renal lymph nodes may be selected on the dialog screen d3 shown in FIG. 12 as the names of the two separated lesions g11 and g12. Thereby, in the determination result table of VISIT1, the same lesion area ID as that of one lesion area g1 before separation in the baseline determination result table is assigned to the names of the two lesion areas g11 and g12 after separation. , Associated with the lesion part of the baseline.

FIG. 14 shows an example of a table of determination results of VISIT1 when a lesion is separated.
As shown in FIG. 14, the lesion having the name of the renal lymph node to which the lesion ID of 2 is assigned in the baseline is separated in VISIT1, and thus the same lesion ID of 2 is assigned to the two separated lesions. ing. The name of the lesion may be the same renal lymph node, but a new name, for example, renal lymph nodes 1 and 2 may be given for distinction.

  Note that the lesion part to which the six lesion part IDs in the determination result table shown in FIG. 14 are assigned is not in the baseline, but is a newly appearing lesion part in VISIT1, and the new name and the lesion part ID are displayed. It is a given lesion.

  Further, as shown in FIG. 13A, two lesions g2 and g3 to which the names of the non-lymph node A and the non-lymph node B are given in the baseline are shown in FIG. 13C in VISIT1. As shown in FIG. 12, the names of the non-lymph node A and the non-lymph node B before the fusion are displayed on the dialog screen d3 shown in FIG. 12 as the name of the single lesion part g4 after the fusion. Just choose. Thereby, in the determination result table of VISIT1, two lesion part IDs same as the two lesion parts g2 and g3 before fusion in the table of the determination result of baseline are added to the name of one lesion part g4 after fusion. Assigned and associated with a baseline lesion.

FIG. 15 shows an example of a table of determination results of VISIT1 when a lesion part is fused.
As shown in FIG. 15, the lesions with the names of non-lymph nodes A and B, which were assigned 3 and 4 lesion IDs at the baseline, respectively, were fused in VISIT1, so the same 3 and Both four lesion IDs are assigned. The name of the lesion may be either the same non-lymph node A or non-lymph node B, but a new name such as non-lymph node A + B may be given for distinction.

  On the other hand, when it is selected to use a new name in the input field d32 (step S14; N), the user terminal 10 displays the dialog screen d3 as a dialog screen for editing the name of the new lesion shown in FIG. Switch to d2 and display. When the operation unit 14 accepts input of the name, type, and site of the lesion on the dialog screen d2, the user terminal 10 accepts input from the control unit 11 to the table of determination results of VISITx. In addition to writing the name of the lesion, etc., a new lesion ID is assigned and written, and stored in the storage unit 12 (step S16).

Next, the user terminal 10 uses the control unit 11 to determine the series ID of the medical image in which the annotation d11 or d12 is arranged, the slice position in the series, and the position in the medical image, and the determination result of the position of the lesioned part by the determining doctor. Are written in the table of determination results of VISITx in association with the lesion ID.
Further, the length of the ruler annotation d11 is measured by the control unit 11, and the measured value is written in the VISITx determination result table in association with the lesion ID as the lesion size determination result. 12 (step S17).

  In addition, when the user terminal 10 receives the selection input of the determination doctor in the input field d33 of the dialog screen d3 by the operation unit 14, the control unit 11 determines whether each lesion is a target lesion or a non-target lesion in the determination result table. The evaluation of the measurable lesion or the unmeasurable lesion is written in the VISITx determination result table (see FIG. 14 or FIG. 15) and stored in the storage unit 12 (step S18).

  Each time the user terminal 10 performs an operation of placing the annotation d11 or d12 by the determining doctor until an operation for ending the detection of the lesion is received by the operation unit 14 (Step S19; N), the name of the lesion described above, The input and storage of the position and size determination results are repeated (steps S13 to S18).

When an operation for ending the detection of a lesioned part is accepted (step S19: Y), the user terminal 10 causes the display unit 15 to display an operation screen on which a determination result of a treatment effect can be selected.
Specifically, the user terminal 10 displays an input field for the determination result of the effects of the target lesion and the non-target lesion on the operation screen. The decision-making physician enters the complete response (CR: Complete Response), partial response (PR: Partial Response), stable (SD: Stable Disease), progression (PD: Progressive disease), and unevaluable ( Evaluation such as NE (Not Evaluable) can be selected and input. In addition, the judging doctor can selectively input evaluations such as CR, incomplete response (IR), SD, PD, NE, etc., in the input field for the effect of the non-target lesion.

The judging doctor performs the above evaluation on the basis of the diameter sum of the target lesion or the non-target lesion, the reduction ratio of the diameter sum, the increase ratio, and the like. As reference information at the time of evaluation, the user terminal 10 acquires the determination result of the size of each lesion from the determination result table of VISITx, and calculates the diameter sum of the target lesion or the non-target lesion, the reduction ratio of the diameter sum, and the increase ratio. Etc. are preferably calculated and displayed. For example, according to the RECIST guideline, the reduction ratio or the like can be calculated by dividing the VISITx diameter sum by the baseline sum. The increase rate can be calculated by dividing the diameter sum of VISITx by the minimum diameter sum of the diameter sums of VISITx multiple times.
From the viewpoint of leaving a trail, items such as a reduction rate and an increase rate are added to the table of determination results of VISITx, and the calculated diameter sum, reduction rate, increase rate, etc. are used as 1 of the determination result of the lesion size. As a matter of fact, it is preferable to store in a determination result table of VISITx.

In addition, the user terminal 10 displays an input field for the presence or absence of the appearance of a new lesion and an input field for the overall effect on the operation screen. The judgment doctor can selectively input an evaluation of whether or not there is a new lesion in the input field for the presence or absence of the new lesion. In addition, the judging doctor selects the above-mentioned CR, PR, SD, PD, NE, etc. in the input column of the total effect according to the combination of the effect of the target lesion, the effect of the non-target lesion, and the presence or absence of the appearance of a new lesion. Can be entered.
The user terminal 10 determines the effect of each target lesion and each non-target lesion, the presence / absence of a new lesion, and the overall effect received by the operation unit 14 from the VISITx determination result table (FIG. 14 and FIG. 14). 15) and is stored in the storage unit 12 (step S20).

  After storing the determination result of the therapeutic effect, the user terminal 10 transmits a VISITx determination result table to the management server 20 via the communication unit 13. The management server 20 stores the received determination table of VISITx, writes the date of today as a determination date, and stores it in the determination result management table (see FIG. 6) (step S21). The determination result table and the determination result management table are associated with each other by the determination result ID, and the determination result management table is associated with the determination result ID and the determination count n. n can be stored as a determination result.

After the determination doctor determines the baseline and VISITx, the determination doctor may perform the determination again from the baseline according to the change with time of the lesioned part. In addition, after a determination doctor makes a determination, another determination doctor may perform the determination again. As described above, when the determination is performed a plurality of times, the determination result of the position and the size may be different even in the same lesion portion.
For example, the lesion g5 in which the annotation d11 is arranged as shown in FIG. 16 (a) at the time of the first determination is the lesion in which the annotation d11 is arranged in FIG. 16 (b) at the time of the second determination. Compared with the part g6, the position and the size are different. Further, as shown in FIG. 16C, the lesion g7 in which the annotation d11 is arranged at the time of the third determination is different in position and size from the first lesion g5 and the second lesion g6. .

Thus, since the determination result of the lesioned part and the effect of the treatment is different if the determination number n is different, when the determination is performed again, the effect determination system 1 stores all of the determination results of a plurality of times, and the arbitrary determination number n A new determination result ID is assigned to the determination result of each determination count n so that the determination result can be read.
When there are a plurality of determination results for each examination imaging of the baseline and VISITx, the determination result of the lesion size differs depending on the determination count n. In order to identify which determination number n in the baseline the determination of each determination number n of VISITx is based on, the effect determination system 1 compares the size of the lesion in the medical image of VISITx. The same lesion site ID as the baseline lesion site is assigned and the lesion sites are associated with each other. Based on the presence or absence of the same lesion ID, the correspondence between the determination results of the determination number n of the baseline and VISITx can be specified.

FIG. 17 shows the correspondence between the lesions in the medical image corresponding to each examination imaging of the baseline and VISIT1 and VISIT2.
As shown in FIG. 17, after the determining doctor determines the size of the lesion in the medical image of the baseline, the determining physician determines the size of the same lesion as the baseline in the medical image of VISIT 1 Observe changes in lesion size from At this time, in the effect determination system 1, the determination results such as the size of the lesion part of the baseline and VISIT1 and the effect of the treatment are stored as the determination results of the determination number 1, respectively, and each lesion part corresponds by the same lesion part ID. Attached. In FIG. 17, the associated lesions are connected by a solid line.
Thereafter, when the determination doctor performs the determination of VISIT 1 again, the determination result is stored as a determination result of the determination count 2. The determination of VISIT1 determination number 2 also uses the lesion part detected by the determination of baseline determination number 1 as a reference for size comparison, so the same lesion part ID is assigned to the lesion part for which the input of the same name is accepted. Are assigned and associated.

When the VISIT2 medical image is obtained and then redoed from the determination of the baseline, the deciding physician makes the determinations of VISIT1 and 2 based on the lesion part detected in the determination of the redoed baseline determination number 2. As shown in FIG. 17, the determination results of the baseline and VISIT 1 and 2 at this time are stored as the determination results of the determination times 2, 3 and 1, respectively, and the lesion part common to each determination result has the same lesion part ID. Are associated with each other.
Further, when the determination is performed again from the baseline, the determining doctor performs the determinations of VISITs 1 and 2 using the same name with reference to the lesion part detected in the determination of the determination number 3 of the determined baseline. The determination results of these baselines, VISIT 1 and 2, are stored as the determination results of the determination counts 3, 4 and 2, respectively. In each determination result, the lesion part which has received the input of the same name is associated with the same lesion part ID.

The user terminal 10 acquires, from the management server 20, the determination result of the baseline and VISITx lesion location and size, and the clinical trial effect stored in the management server 20 from the management server 20. Can be displayed.
The user terminal 10 first displays the determination result of the baseline having the maximum determination count n and the determination result of the determination count n of VISITx in which the lesion is associated with the same lesion ID as the determination result.
For example, when displaying the determination result of the baseline and VISIT2, the number of determinations of the latest determination result of the baseline is 3, as shown in FIG. Since it is the determination result of the determination count 2 of VISIT2 that the lesion portion is associated with the same lesion ID as the determination result of the baseline determination count 3, the user terminal 10 acquires these determination results. indicate.

FIG. 18 shows an example of a determination result display screen.
As shown in FIG. 18, the user terminal 10 divides the display screen d4 into left and right, and displays the baseline medical image and the determination result of the determination count 3 which is the latest determination result of the baseline in the left display area d41. To do. In addition, the user terminal 10 displays the determination result of the determination number 2 of VISIT2 in which the lesion part is associated with the same lesion part ID as the determination result of the baseline determination number 3 in the right display area d42.
Specifically, from the determination result of the size and position of the lesioned part, the control unit 11 obtains the annotations d11 and d12 having the same length as the input of the determination result, the measured value of the size of the lesioned part, and the like. It is acquired or calculated and displayed on the display screen d4. Alternatively, the control unit 11 may acquire and display the evaluation of the overall effect from the determination result of the clinical trial effect.

The judgment doctor can select a judgment result of the judgment number n to be displayed from a plurality of judgment results with respect to the baseline by using the pull-down menu d43 on the display screen d4.
When the user terminal 10 receives any selection input from the list of determination results for each determination number n for the baseline displayed in the pull-down menu d43, the user terminal 10 acquires the determination result for the received determination number n from the management server 20. Then, the determination result being displayed is switched to the acquired determination result and displayed. Further, the user terminal 10 acquires the determination result of the determination number n of VISIT2 in which the lesion part is associated with the same lesion part ID as the acquired determination result of the baseline determination number n, and the determination result of the currently displayed VISITx Switch to the determination result that has been acquired.

  For example, when the selection input of the determination result of the baseline determination frequency 2 is received, the user terminal 10 determines that the lesion area has the same lesion area ID as the determination result of the baseline determination frequency 2 as shown in FIG. The determination result of the determination number 1 of the associated VISIT 2 is acquired from the management server 20 and displayed.

  The judgment doctor can select the judgment result of the judgment number n displayed by the pull-down menu d44 of the display screen d4 shown in FIG. 18 not only for the baseline but also for VISIT2. The user terminal 10 switches and displays the determination result of VISIT2 being displayed to the determination result of the determination number n of accepting the selection input. In this case, the user terminal 10 switches the baseline determination result to the determination result of the determination number n of the baseline in which the lesion part is associated with the same lesion ID as the determination result n of the displayed determination number VISIT2. indicate.

In addition, the determination doctor can select an arbitrary determination result of VISITx.
For example, when receiving the selection input of the determination result of the determination number 3 of VISIT1, the user terminal 10 switches the determination result of VISIT2 to the determination result of the determination number 3 of VISIT1 and displays it. As shown in FIG. 20, the lesion portion is associated with the same lesion portion ID as the determination result of the determination number 3 of VISIT 1 is the determination result of the determination number 2 of the baseline. The line determination result is switched to the determination result of the determination count 2 and displayed.

  As described above, the effect determination system 1 of the present embodiment includes the display unit 15 that displays one or more series of medical images obtained by performing at least one examination imaging before and after the start of the clinical trial. The operation unit 14 receives an input of the determination result of the treatment effect determined by the determining physician according to the size of the lesion in the medical images of each series before and after the start of the clinical trial displayed by the display unit 15. And the storage unit 12 for storing the determination result received by the operation unit 14, and the input of the determination result of the effect of multiple treatments for each examination imaging before and after the start of the trial is received by the operation unit 14. And a control unit 11 that stores all of the accepted determination results in the storage unit 12.

  As a result, it is possible to save all of the determination results of multiple times for each examination radiograph (baseline) before the start of the clinical trial and each examination radiograph after the start of the clinical trial (VISITx). Can be left as. Even when auditing is performed, not only the final determination result but also the past determination results up to the final determination result can be provided as the basis for the final determination result.

Moreover, in the said embodiment, the user terminal 10 receives the input of the determination result of the magnitude | size of the 1 or several lesion part in the medical image which the determination doctor determined with the effect of treatment with the operation part 14, and the control part 11, each time an input of a treatment effect determination result is received by the operation unit 14, the received treatment effect determination result and one or more lesion size determination results are used as the number of treatment effect determinations. The data can be stored in the storage unit 12 in association with each other.
As a result, not only the determination result of the treatment effect but also the determination result of the size of the lesion as the basis for the determination of the treatment effect can be saved for each determination.

In addition, the user terminal 10 receives an input of the determination result of the position of one or a plurality of lesions in the medical image determined by the determination doctor together with the effect of the treatment by the operation unit 14, and the control unit 11 performs the operation by the operation unit 14. Each time an input of the determination result of the treatment effect is received, the determination result of the received treatment effect and the determination result of the position of one or a plurality of lesions are stored in the storage unit 12 in association with the number of determinations of the treatment. be able to.
As a result, not only the determination result of the treatment effect but also the determination result of the position of the lesion part as the basis for the determination of the treatment effect can be saved for each determination.

The user terminal 10 receives the input of the names of one or more lesions in the medical images of each series before the start of the trial using the operation unit 14, and uses the received names for each series after the start of the trial. The input of the name of one or a plurality of lesions in the medical image is received, and the control unit 11 receives the input of the same name among the one or the plurality of lesions received by the operation unit 14 Can be associated with each examination image before and after the start of the clinical trial, and the name of each received lesion can be stored in the storage unit 12.
Thereby, the determination result of each determination frequency with respect to each examination imaging before and after the start of the clinical trial can be associated with the lesion part whose size is compared in each determination.

  The user terminal 10 receives an input of the number of determinations of the determination result to be displayed among a plurality of determination results received for each examination imaging before and after the start of the clinical trial by the operation unit 14, and the control unit 11 Of the determination results of a plurality of times, the determination result of the number of determinations accepted by the operation unit 14 can be acquired from the storage unit 12 and displayed on the display unit 15.

The user terminal 10 uses the control unit 11 to determine the number of determinations in which a lesioned part is associated among a plurality of determination results for examination imaging before the start of the trial and a plurality of determination results for examination imaging after the start of the trial. Each determination result can be acquired and displayed.
Thereby, the determination result of the frequency | count of determination that the lesioned part which compared the magnitude | size among the determination results of several times before the trial start and after the start can be provided.

Conventionally, even when a plurality of determinations are performed for each of the baseline and VISITx inspection imaging, only the last determination result can be saved, and the past determination result is overwritten by the latest determination result. .
Even if past determination results are simply stored, the history cannot be effective as a trail stored by the effect determination system 1 of the present embodiment. As described above, if the number of determinations for the baseline and VISITx is different, the determination result such as the size of the lesion is also different. If the past determination results are simply saved, as shown in FIG. Moreover, it is because it is not known in which number of determinations n the lesions determined are compared with each other.

In addition, when the lesion part is separated or fused with time, the correspondence between the lesion part before and after separation or fusion becomes important information for determining the effect of treatment. However, conventionally, the lesion between the baseline and VISITx examination images could not be associated, and as shown in FIG. 21, the lesion in the medical image of the baseline is any lesion of the VISITx medical image. It was not possible to share information on the lesion between each examination radiograph.
On the other hand, the effect determination system 1 according to the present embodiment receives an input of the name of the lesion in the baseline medical image, and inputs the same name as the name received in the baseline of the lesion in the VISIT medical image. The input of the name of the department can be accepted. In order to save the determination result by associating the lesion in the baseline medical image with the lesion in the VISITx medical image that has received an input with the same name as the baseline lesion, separation or fusion is performed. It is possible to easily grasp the correspondence between the lesioned parts and the correspondence between the determination results of the number of determinations of each examination photographing.

The above embodiment is a preferred example of the present invention, and the present invention is not limited to this. Modifications can be made as appropriate without departing from the spirit of the present invention.
For example, as an example of the configuration of the effect determination system 1, FIG. 1 shows a configuration of a client server model including a plurality of user terminals 10 and a management server 20, but one computer device includes a user terminal 10 and a management server 20. The structure provided with a function may be sufficient.

  Further, as a computer-readable medium for a program that causes the user terminal 10 and the management server 20 to execute the above processing procedure, a non-volatile memory such as a ROM or a flash memory, or a portable recording medium such as a CD-ROM may be applied. Is possible. A carrier wave is also used as a medium for providing program data via a communication line.

DESCRIPTION OF SYMBOLS 1 Effect determination system 10 User terminal 11 Control part 12 Storage part 13 Communication part 14 Operation part 15 Display part 20 Management server A1 Clinical trial management system A2 Image management system C Clinical trial execution system

Claims (7)

An effect determination system comprising a user terminal used by a doctor and a management server that manages information input in the user terminal,
The user terminal is
Display control means for displaying on the display means one or more series of medical images obtained by performing at least one examination imaging before and after the start of the clinical trial;
An operation means for receiving an input of a determination result of a treatment effect determined by a doctor according to the size of a lesion in each series of medical images before and after the start of the trial displayed on the display means;
Associating the determination result of the effect of the treatment with respect to each examination imaging before and after the start of the trial for which the input has been received by the operation means , with information associated with the number of determinations with respect to the examination imaging acquired from the management server Te, a transmission unit to be transmitted to the management server,
With
The management server is
The medical image requested from the user terminal is transmitted to the user terminal, and based on the transmission of the medical image, the number of determinations for examination imaging related to the medical image is counted.
Storage means for storing the number of determinations for each inspection image in association with information associated with the number of determinations;
On the basis of the information associated with the number of determinations that have been transmitted from the user terminal, and the determination result of the effect of the transmitted said treatment from said user terminal, against the test shooting according to the determination result of the effect of the therapeutic determine in association with a constant number of times, and a control means for storing in said memory means,
An effect determination system comprising: The operation means receives an input of a determination result of the size of one or a plurality of lesions in the medical image determined by a doctor together with the effect of the treatment,
The transmission unit, the size of the determination result of the determination result of the therapeutic effect of accepting the input and the one or more lesions by the operation means, in association with the number of determinations and associated information, wherein To the management server,
The control means , based on the information associated with the determination count transmitted from the user terminal, the determination result of the treatment effect transmitted from the user terminal and the size of the one or more lesions effect judging system according to claim 1, the determination result in association with the previous SL-size constant number, and characterized in that stored in the storage means. The operation means accepts an input of a determination result of a position of one or a plurality of lesions in the medical image determined by a doctor together with the effect of the treatment,
The transmission unit associates the determination result of the effect of the treatment received the input by the operation unit and the determination result of the position of the one or more lesions with the information associated with the determination count, and the management To the server,
The control means determines the determination result of the effect of the treatment transmitted from the user terminal and the positions of the one or more lesions based on information associated with the determination count transmitted from the user terminal. the results, in association with pre-Symbol-size constant number, the effect determination system according to claim 1 or 2, characterized in that stored in the storage means. The operation means receives an input of the name of one or a plurality of lesions in each series of medical images before the start of the trial, and uses the received names in the medical images of each series after the start of the trial. Accepts the input of one or more lesion names
The transmission means transmits the names of one or more lesions received by the operation means to the management server,
The control means associates the lesion part that has received the input of the same name among one or a plurality of lesion parts that have received the input of the name by the operation means between the examination imaging before and after the start of the trial. 4. The effect determination system according to claim 2, wherein the name of each received lesion is stored in the storage unit. The operation means accepts an input of the number of determinations of a determination result to be displayed among a plurality of determination results received for each examination imaging before and after the start of the clinical trial,
The said display control means acquires the determination result of the determination frequency | count which received the input by the said operation means from the said memory | storage means among the said multiple determination results, and displays it on the said display means. 4. The effect determination system according to 4.   The display control means determines that a lesion portion having the same name is associated with a plurality of determination results for examination imaging before the start of the trial and a plurality of determination results for examination imaging after the start of the trial. 6. The effect determination system according to claim 5, wherein a determination result of the number of times is acquired from the storage unit and displayed on the display unit. A determination result storage method executed by an effect determination system comprising a user terminal used by a doctor and a management server that manages information input in the user terminal,
The display control means of the user terminal causes the display means to display one or more series of medical images obtained by performing at least one examination imaging before and after the start of the trial;
According to the size of the lesion in each series of medical images before and after the start of the trial displayed on the display means, the input of the determination result of the treatment effect determined by the doctor is input to the user terminal. Steps received by the operating means;
The number of determinations for the examination imaging obtained from the management server for the results of the determination of the effect of the treatment on each examination imaging before and after the start of the clinical trial that was received by the operation means by the transmission means of the user terminal Associating with the information associated with and transmitting to the management server;
Transmitting the medical image requested from the user terminal to the user terminal by the control means of the management server, and counting the number of determinations for examination imaging related to the medical image based on the transmission of the medical image;
Correspondence between the number of determinations for each examination image stored in the storage unit of the management server and the information associated with the number of determinations by the control unit of the management server, and the determination transmitted from the user terminal based on the information associated with the number, associates the determination result of the effect of the transmitted said treatment from said user terminal, and determine the constant number against the test shooting according to the determination result of the effect of the treatment, the Storing in the storage means;
A determination result storing method characterized by comprising: