Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04489992
Status:
RECRUITING
Last Update Posted:
2023-05-26
First Post:
2020-07-17
Brief Title:
Experiment on the Use of Innovative Computer Vision Technologies for Analysis of Medical Images in the Moscow Healthcare System
Sponsor:
Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
Organization:
Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
Study Overview
Official Title:
Experiment on the Use of Innovative Computer Vision Technologies for Analysis of Medical Images in the Moscow Healthcare System
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is planned to integrate various services based on computer vision technologies for analysis of the certain type of x-ray study into Moscow Unified Radiological Information Service hereinafter referred to as URIS
As a result of using computer vision-based services it is expected
1 Reducing the number of false negative and false positive diagnoses
2 Reducing the time between conducting a study and obtaining a report by the referring physician
3 Increasing the average number of radiology reports provided by a radiologist per shift
As a result of using computer vision-based services it is expected
1 Reducing the number of false negative and false positive diagnoses
2 Reducing the time between conducting a study and obtaining a report by the referring physician
3 Increasing the average number of radiology reports provided by a radiologist per shift
Detailed Description:
Recently a growth in the number of radiology studies across multiple modalities has been observed alongside the modest increase in staffing levels This carries higher risks of increased workload and efficiency losses The integration of computer vision-based services into URIS will improve the radiologists productivity and job performance
Existing prerequisites for conducting the study
1 Increasing the number of preventive and diagnostic radiological studies entails the growing workload for radiologists and increased risk of interpretation errors which in turn leads to the decrease in quality of medical care
2 When a radiologist opens a worklist of studies in the absence of special notes heshe writes a report in the random order not being able to select from the list the studies that require the most attention and prompt response studies with pathological findings which increases the time of diagnosis
3 The absence of the structured pre-filled template of report leads to the increase in time for preparing reports
4 A radiologist has to spend considerable time evaluating the dynamics of pathological changes which also increases the time to prepare a report as well as the risk of error
5 Interpretation of preventive studies requires double reading which is implemented inefficiently due to the staff shortage
Study objectives
1 Study the diagnostic accuracy of the Services in accordance with the methodological guidelines No 43 Clinical trials of software based on intelligent technologies diagnostic radiology recommended by the Expert Council on Science of the Moscow Healthcare Department Protocol No 8 of June 25 2019
2 Audit the studies conducted with Services application in order to determine the number of interpretation errors and compare it with the audit result without their application hypothesis 1
3 Conduct timekeeping to estimate time for preparing a report and the total number of evaluated studies with and without using the Services hypothesis 23
4 Conduct a survey of radiologists who use the Services in their work in order to determine their opinion about the implementation of innovative technologies in the diagnostic process
METHODOLOGY
1 The Experiment is carried out by the Moscow Healthcare Department in accordance with Regulation No 43 of January 24 2020 On approval of the procedure and conditions for conducting the Experiment on the use of innovative computer vision technologies for analysis of medical images and further application in Moscow healthcare system
2 The experiment is conducted on the next types of studies
1Detection of CT signs consistent with COVID-19 coronavirus lung involvement Chest CT 2 Emphysema extent Chest CT 3 Detection of CT signs consistent with malignant neoplasm in the lungs Chest CT 4 Detection of LDCT signs consistent with malignant neoplasm in the lungs Chest LDCT 5 Detection and localization of compression vertebral fractures with a degree of vertebral body deformity of over 25 according to the Genant semi-quantitative scale grades 2-3 Chest CT 6 Detection of free pleural fluid effusion Chest CT 7 Detection of enlarged intrathoracic lymph nodes lymphadenopathy Chest CT 8 Detection of bronchiectasis Chest CT 9 Detection of CT signs consistent with pulmonary tuberculosis Chest CT 10 Coronary calcium score Chest CT LDCT 11 Paricardial fat volume Chest CT 12 Dilation of ascending and descending thoracic aortas Chest CT LDCT 13 Dilation of the pulmonary trunk Chest CT LDCT 14 Detection of sarcoidosis Chest CT 15 Detection of signs consistent with the impairment of lung airness Chest CT 16 Detection of signs consistent with the focal lesions in the chest bones Chest CT 17 Detection of CT signs consistent with rib fracture Chest CT 18 Detection of signs of urolithiasis Abdominal CT 19 Detection of signs consistent with the focal lesions in the skeleton bones Abdominal CT 20 Detection of liver lesions Abdominal CT 21 Detection of CT signs consistent with gallbladder stones Abdominal CT 22 Detection of CT signs consistent with renal lesions Abdominal CT 23 Measuring the abdominal aorta dilation Abdominal CT 24 Detection of adrenal lesions AbdominalChest CT 25 Detection and localization of compression vertebral fractures with a degree of vertebral body deformity of over 25 according to the Genant semi-quantitative scale grades 2-3 Abdominal CT 26 Automation of routine liver measurements dimensions liver density choledochus diameter portal vein diameter Abdominal CT 27 Automation of routine kidney measurements kidney size pelvicalyceal system size Abdominal CT 28 Automation of routine measurements of spleen and pancreas size density of the spleen and pancreas Abdominal CT 29 Detection of acute ischemic stroke and its ASPECTS score Head CT 30 Detection of hemorrhage and its automatic volume calculation in ml or cm³ Head CT 31 Automation of routine measurements ventriculometry displacement of median structures measurement of the craniovertebral junction Head CT 32 Detection and localization of at least 7 signs consistent with the priority disease Chest XR 33 Detection of signs at least one consistent with bone fracture MSS XR 34 Detection of radiologic signs at least one consistent with arthrosis of the joints MSS XR 35 Detection of radiological signs at least one consistent with deforming arthrosis of the hip MSS XR 36 Detection of radiological signs at least one consistent with the fracture of the shoulder joint bones MSS XR 37 Detection of radiological signs at least one consistent with the fracture of the hip joint bones MSS XR 38 Detection of radiological signs at least one consistent with the fracture of the ankle joint bones MSS XR
39 Detection of reduced pneumatization opacity of the paranasal sinuses Head XR 40 Detection of signs at least one consistent with transverse flat foot MSS XR 41 Detection of signs at least one consistent with the longitudinal flat foot in the lateral plane MSS XR 42 Detection of the signs of osteoporosis detection and localization of compression vertebral fractures with a degree of height loss of over 25 as well as the radio density measurements of vertebral bodies Spine XR 43 Detection of signs consistent with osteochondrosis in the frontal andor sagittal plane Spine XR 44 Detection of signs consistent with scoliosis in the frontal plane Spine XR 45 Detection of signs consistent with spondylolisthesis in the sagittal plane Spine XR 46 Detection and localization of findings consistent with breast cancer MMG 47 Detection of multiple sclerosis Brain MRI 48 Detection and localization of intracranial neoplasms extracerebral intracerebral Brain MRI 49 Automation of routine measurements ventriculometry displacement of median structures measurement of the craniovertebral junction changes in white matter intracranial measurements Brain MRI 50 Detection of signs consistent with the focal lesions in the cervical spinal cord Cervical spine MRI 51 Detection and localization of MRI signs at least one consistent with degenerative changes in the cervical discs on sagittal and axial T2-WI Cervical spine MRI 52 Detection and localization of MRI signs at least one consistent with degenerative changes in the thoracic discs on sagittal and axial T2-WI Thoracic spine MRI 53 Detection of signs consistent with the focal lesions in the thoracic spinal cord Thoracic spine MRI 54 Detection and localization of MRI signs at least one consistent with degenerative changes in the lumbosacral discs on sagittal and axial T2-WI Lumbosacral spine MRI 55 Detection of signs consistent with the focal lesions in the lumbosacral spinal cord Lumbosacral spine MRI 56 Detecting signs consistent with the areas of cartilage breakdown chondromalacia along the articular surfaces of the knee and the patellofemoral joint Knee joint MRI 57 Automated routine measurements of the prostate gland dimensions Lesser pelvis MRI 58 Automated routine measurements of the uterus corpus and cervix position dimensions displacements Lesser pelvis MRI
3 For each Service during the Experiment a certain number of studies is provided for processing based on their type
1 CTLDCT - 30 250 studies
2 XR - 55 000 studies
3 MMG - 48 500 studies
4 MRI - 22 500 studies
4 A methodology for including services in the Experiment has been developed For each Service the participation process in the Experiment consists of the following stages
1 selection
2 the preparatory stage
3 the main stage
4 the final stage
During the Experiment a radiologist will routinely be able to
work on a sorted list of patients triage
work with images processed by the Service
work with a pre-filled template of the radiological report on each study
evaluate the work of the Service according to the developed questionnaire During the Experiment a patient will receive the individual plan of the follow-up support It includes preventive examinations or observation as well as treatment by a specialist
Systematization and final analysis of the Experiment results is carried out within three months from the completion date of the last Service participation in the Experiment
Based on the results of the Experiment recommendations can be prepared on the possibility to register certain services as a medical device software
Existing prerequisites for conducting the study
1 Increasing the number of preventive and diagnostic radiological studies entails the growing workload for radiologists and increased risk of interpretation errors which in turn leads to the decrease in quality of medical care
2 When a radiologist opens a worklist of studies in the absence of special notes heshe writes a report in the random order not being able to select from the list the studies that require the most attention and prompt response studies with pathological findings which increases the time of diagnosis
3 The absence of the structured pre-filled template of report leads to the increase in time for preparing reports
4 A radiologist has to spend considerable time evaluating the dynamics of pathological changes which also increases the time to prepare a report as well as the risk of error
5 Interpretation of preventive studies requires double reading which is implemented inefficiently due to the staff shortage
Study objectives
1 Study the diagnostic accuracy of the Services in accordance with the methodological guidelines No 43 Clinical trials of software based on intelligent technologies diagnostic radiology recommended by the Expert Council on Science of the Moscow Healthcare Department Protocol No 8 of June 25 2019
2 Audit the studies conducted with Services application in order to determine the number of interpretation errors and compare it with the audit result without their application hypothesis 1
3 Conduct timekeeping to estimate time for preparing a report and the total number of evaluated studies with and without using the Services hypothesis 23
4 Conduct a survey of radiologists who use the Services in their work in order to determine their opinion about the implementation of innovative technologies in the diagnostic process
METHODOLOGY
1 The Experiment is carried out by the Moscow Healthcare Department in accordance with Regulation No 43 of January 24 2020 On approval of the procedure and conditions for conducting the Experiment on the use of innovative computer vision technologies for analysis of medical images and further application in Moscow healthcare system
2 The experiment is conducted on the next types of studies
1Detection of CT signs consistent with COVID-19 coronavirus lung involvement Chest CT 2 Emphysema extent Chest CT 3 Detection of CT signs consistent with malignant neoplasm in the lungs Chest CT 4 Detection of LDCT signs consistent with malignant neoplasm in the lungs Chest LDCT 5 Detection and localization of compression vertebral fractures with a degree of vertebral body deformity of over 25 according to the Genant semi-quantitative scale grades 2-3 Chest CT 6 Detection of free pleural fluid effusion Chest CT 7 Detection of enlarged intrathoracic lymph nodes lymphadenopathy Chest CT 8 Detection of bronchiectasis Chest CT 9 Detection of CT signs consistent with pulmonary tuberculosis Chest CT 10 Coronary calcium score Chest CT LDCT 11 Paricardial fat volume Chest CT 12 Dilation of ascending and descending thoracic aortas Chest CT LDCT 13 Dilation of the pulmonary trunk Chest CT LDCT 14 Detection of sarcoidosis Chest CT 15 Detection of signs consistent with the impairment of lung airness Chest CT 16 Detection of signs consistent with the focal lesions in the chest bones Chest CT 17 Detection of CT signs consistent with rib fracture Chest CT 18 Detection of signs of urolithiasis Abdominal CT 19 Detection of signs consistent with the focal lesions in the skeleton bones Abdominal CT 20 Detection of liver lesions Abdominal CT 21 Detection of CT signs consistent with gallbladder stones Abdominal CT 22 Detection of CT signs consistent with renal lesions Abdominal CT 23 Measuring the abdominal aorta dilation Abdominal CT 24 Detection of adrenal lesions AbdominalChest CT 25 Detection and localization of compression vertebral fractures with a degree of vertebral body deformity of over 25 according to the Genant semi-quantitative scale grades 2-3 Abdominal CT 26 Automation of routine liver measurements dimensions liver density choledochus diameter portal vein diameter Abdominal CT 27 Automation of routine kidney measurements kidney size pelvicalyceal system size Abdominal CT 28 Automation of routine measurements of spleen and pancreas size density of the spleen and pancreas Abdominal CT 29 Detection of acute ischemic stroke and its ASPECTS score Head CT 30 Detection of hemorrhage and its automatic volume calculation in ml or cm³ Head CT 31 Automation of routine measurements ventriculometry displacement of median structures measurement of the craniovertebral junction Head CT 32 Detection and localization of at least 7 signs consistent with the priority disease Chest XR 33 Detection of signs at least one consistent with bone fracture MSS XR 34 Detection of radiologic signs at least one consistent with arthrosis of the joints MSS XR 35 Detection of radiological signs at least one consistent with deforming arthrosis of the hip MSS XR 36 Detection of radiological signs at least one consistent with the fracture of the shoulder joint bones MSS XR 37 Detection of radiological signs at least one consistent with the fracture of the hip joint bones MSS XR 38 Detection of radiological signs at least one consistent with the fracture of the ankle joint bones MSS XR
39 Detection of reduced pneumatization opacity of the paranasal sinuses Head XR 40 Detection of signs at least one consistent with transverse flat foot MSS XR 41 Detection of signs at least one consistent with the longitudinal flat foot in the lateral plane MSS XR 42 Detection of the signs of osteoporosis detection and localization of compression vertebral fractures with a degree of height loss of over 25 as well as the radio density measurements of vertebral bodies Spine XR 43 Detection of signs consistent with osteochondrosis in the frontal andor sagittal plane Spine XR 44 Detection of signs consistent with scoliosis in the frontal plane Spine XR 45 Detection of signs consistent with spondylolisthesis in the sagittal plane Spine XR 46 Detection and localization of findings consistent with breast cancer MMG 47 Detection of multiple sclerosis Brain MRI 48 Detection and localization of intracranial neoplasms extracerebral intracerebral Brain MRI 49 Automation of routine measurements ventriculometry displacement of median structures measurement of the craniovertebral junction changes in white matter intracranial measurements Brain MRI 50 Detection of signs consistent with the focal lesions in the cervical spinal cord Cervical spine MRI 51 Detection and localization of MRI signs at least one consistent with degenerative changes in the cervical discs on sagittal and axial T2-WI Cervical spine MRI 52 Detection and localization of MRI signs at least one consistent with degenerative changes in the thoracic discs on sagittal and axial T2-WI Thoracic spine MRI 53 Detection of signs consistent with the focal lesions in the thoracic spinal cord Thoracic spine MRI 54 Detection and localization of MRI signs at least one consistent with degenerative changes in the lumbosacral discs on sagittal and axial T2-WI Lumbosacral spine MRI 55 Detection of signs consistent with the focal lesions in the lumbosacral spinal cord Lumbosacral spine MRI 56 Detecting signs consistent with the areas of cartilage breakdown chondromalacia along the articular surfaces of the knee and the patellofemoral joint Knee joint MRI 57 Automated routine measurements of the prostate gland dimensions Lesser pelvis MRI 58 Automated routine measurements of the uterus corpus and cervix position dimensions displacements Lesser pelvis MRI
3 For each Service during the Experiment a certain number of studies is provided for processing based on their type
1 CTLDCT - 30 250 studies
2 XR - 55 000 studies
3 MMG - 48 500 studies
4 MRI - 22 500 studies
4 A methodology for including services in the Experiment has been developed For each Service the participation process in the Experiment consists of the following stages
1 selection
2 the preparatory stage
3 the main stage
4 the final stage
During the Experiment a radiologist will routinely be able to
work on a sorted list of patients triage
work with images processed by the Service
work with a pre-filled template of the radiological report on each study
evaluate the work of the Service according to the developed questionnaire During the Experiment a patient will receive the individual plan of the follow-up support It includes preventive examinations or observation as well as treatment by a specialist
Systematization and final analysis of the Experiment results is carried out within three months from the completion date of the last Service participation in the Experiment
Based on the results of the Experiment recommendations can be prepared on the possibility to register certain services as a medical device software
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None