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AI (Artificial Intelligence)NCT04489992

Experiment on the Use of Innovative Computer Vision Technologies for Analysis of Medical Images in the Moscow Healthcare System

An observational study of AI (Artificial Intelligence) and Mammary Cancer, run by Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department at 1 site in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
How many people
133,000 participants
Where
1 siteRussia
Study dates
21 Feb 2020to 1 Jan 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: patients over the age of 18 attending outpatient clinics

Who may be able to join

  • Age (over 18 years)
  • Gender (male and female)
  • Referral for the study
  • Signed informed consent to participate in the Experiment
  • Chest computed tomography and Low-dose computed tomography for lung cancer detection or mammography for breast cancer detection or chest X-ray for lung pathology detection

Who cannot join

  • Another type of study (including a different modality and anatomical area)

Trial locations and contacts

1 site in 1 country.

Kirill Arzamasov, PhD contact

+79152514838

ArzamasovKM@zdrav.mos.ru

Russia1 site, 1 recruiting
  • Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department

    Moscow

    PhD

    Kirill Arzamasov, PhD, +79152514838, ArzamasovKM@zdrav.mos.ru

    Recruiting

Other trials in Russia

About this study

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.
Read the 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, he/she 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 2,3).
  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:

1)Detection 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 (Abdominal/Chest 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).

  1. 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 and/or 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).
  2. For each Service during the Experiment, a certain number of studies is provided for processing based on their type:
  3. CT/LDCT - 30 250 studies;
  4. XR - 55 000 studies;
  5. MMG - 48 500 studies;
  6. MRI - 22 500 studies.
  7. 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:
  8. selection;
  9. the preparatory stage;
  10. the main stage;
  11. 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).

Keywords
AI (Artificial Intelligence), Computed tomography, Low-dose CT, X-ray chest, mammography, COVID-19, Chest--Diseases, Abdomen Disease, Brain Disease, Fractures, Bone
Medical subject headings
Breast Neoplasms, Lung Neoplasms, COVID-19, Brain Diseases, Fractures, Bone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04489992
Study groupRoleWhat they receive
Standard radiology studies with AIThe experiment is conducted on 10 types of studies with AI: 1. Chest CT/ LDCT with different pathologies; 2. Abdominal CT with different pathologies; 3. Head CT with different pathologies; 4. MSS XR with different fractures 5. Spine XR with different pathologies; 6. MMG; 7. Brain MRI with different pathologies; 8. Cervical spine MRI, Lumbosacral spine MR and Thoracic spine MRI with spine pathologies 9. Knee joint MRI 10. Lesser pelvis MRI.
Standard radiology studies without AIThe experiment is conducted on 10 types of studies without AI: 1. Chest CT/ LDCT with different pathologies; 2. Abdominal CT with different pathologies; 3. Head CT with different pathologies; 4. MSS XR with different fractures 5. Spine XR with different pathologies; 6. MMG; 7. Brain MRI with different pathologies; 8. Cervical spine MRI, Lumbosacral spine MR and Thoracic spine MRI with spine pathologies 9. Knee joint MRI 10. Lesser pelvis MRI.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of errors

    Change of at least 30% in the number of errors in interpretation of the studies with using computer vision-based services compared to the number of errors in interpretation without their application.

    Measured: Upon completion, up to 4 years

Secondary outcomes (3)
  1. Report turnaround time

    Change of at least 30% of the time from the study completion to report finalization by a radiologist.

    Measured: Upon completion, up to 3 year

  2. Number of reports

    Change of at least 30% in the number of radiology reports provided by a radiologist per shift.

    Measured: Upon completion, up to 4 years

  3. Change in the errors of services per the feedback form

    Change of at least 30% in computer vision-based services errors as per integrated feedback form for radiologists in the PACS.

    Types of errors:

    1. Technological defect (absent AI-generated series, partially generated AI series, DICOM SR and images mismatch, multiple conflicting results)
    2. Major discrepancy (findings outside the region of interest, irrelevant findings)
    3. Inaccurate diagnosis
    4. Inaccurate lesion localisation
    5. Inaccurate lesion classification
    6. Other (free-text field)

    Measured: Upon completion, up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2020
  2. Study start21 Feb 2020
  3. Primary completion1 Jan 2024 (estimated)
  4. Study completion1 Jan 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Prospective
Enrolment
133,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04489992
Sponsor's protocol ID
2020-3
Status last verified
May 2023
First submitted
17 Jul 2020
Last updated
26 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of AI (Artificial Intelligence) and Mammary Cancer, run by Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kirill Arzamasov, PhD (+79152514838, ArzamasovKM@zdrav.mos.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of errors (time frame: Upon completion, up to 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.

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