Study Aims to Develop and Validate a Generative AI-assistant Designed to Optimize Radiologists' Workflows and to Evaluate Its PerformanceGARWNCT07057830
Generative AI Radiologist's Workstation
An observational study of Study Aims to Develop and Validate a Generative AI-assistant Designed to Optimize Radiologists' Workflows and to Evaluate Its Performance, run by Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department at 2 sites in Russia.
Trial summary
This study aims to develop a generative AI assistant for radiologists to automate the processing of electronic medical records (EMRs) and provide relevant clinical information, optimizing diagnostic interpretation workflows. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Study Aims to Develop and Validate a Generative AI-assistant Designed to Optimize Radiologists' Workflows and to Evaluate Its Performance
- How many people
- 27 participants
- Where
- 2 sitesRussia
- Study dates
- 1 Jul 2025to 1 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: The study population comprises 27 board-certified radiologists from tertiary hospitals, who have more than three years of working experience, proficiency in using UMIAS and no competing research involvement.
Who may be able to join
- Board-certified practicing radiologist;
- ≥3 years of experience in diagnostic imaging;
- Proficiency in using UMIAS systems;
- Signed informed consent form.
Who cannot join
- Participation in other studies;
- Unwillingness to adopt new technologies in daily practice;
- Conflict of interest.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Russia2 sites
MIREA - Russian Technological University
Moscow, 119454
Kirill M. Arzamasov, PhD, MD, +7 (499) 600-80-80, ArzamasovKM@zdrav.mos.ru
Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
Moscow, 127051
Anton V. Vladzymyrskyy, PhD, MD, +7 (495) 276-04-36, VladzimirskijAV@zdrav.mos.ru
About this study
Official title: Advanced AI-powered Workstation for Radiologists Based on Generative Artificial Intelligence
This study aims to develop a generative AI assistant for radiologists to automate the processing of electronic medical records (EMRs) and provide relevant clinical information, optimizing diagnostic interpretation workflows.
Read the detailed description
This study aims to develop and validate a generative AI-assistant designed to optimize radiologists' workflow by automatically processing electronic medical records (EMRs) and generating structured clinical summaries. The AI tool will extract and prioritize relevant patient data to support accurate and efficient interpretation of diagnostic imaging studies.
The study rationale originates from increasing radiology workloads and the need to reduce time spent reviewing EMRs while maintaining diagnostic accuracy. The proposed AI solution specifically targets these issues through advanced natural language processing capabilities, with particular attention to optimizing time efficiency while maintaining or improving diagnostic accuracy.
The study consists of 9 Stages:
Stage 1: Theoretical Foundation.
1.1 Systematic review: comprehensive analysis of existing LLM applications in radiology.
1.2 Healthcare system analysis: evaluation of LLM implementations in clinical settings.
1.3 Expert consensus: semi-structured interviews with 30 practicing radiologists (stratified by experience: junior [<3 years], mid-career [3-10 years], senior [>10 years]) to establish:
- Minimum required clinical data elements;
- Optimal summary format (structured vs. narrative);
- Critical alert thresholds.
Stage 2: Technical Development.
2.1 Medical text processing: formalization of methods for extraction, standardization, and annotation.
2.2 Dataset Curation: methodology for creating representative training datasets from UMIAS (Unified Medical Information and Analytical System).
2.3 Validation Framework: creation of validation methodology for the generative AI-based assistant.
Development and validation of a questionnaire assessing:
- Relevance;
- Completeness (missing critical data);
- Hallucination frequency;
- Terminology/grammar;
- Radiologist satisfaction.
Stage 3: Dataset Development.
Data Source: Retrospective extraction of anonymized EMRs from UMIAS.
Inclusion Criteria:
- Age of the patient at the moment of medical image acquisition >18 years;
- Pathology types: pleuritis, ascites, unspecified masses/lesions, neuropathy;
- Imaging study modalities (performed between January 1, 2020, and May 31, 2025): CT chest (pleural/pulmonary pathologies); CT abdomen/pelvis (ascites/abdominal masses); MRI brain (neuropathy/neurological conditions);
- Complete EMR data (clinical notes, prior imaging reports, lab results, discharge summaries).
Exclusion Criteria:
Cases with technical artifacts on medical images compromising diagnostic quality.
Per-case data collected: physical examination results; two prior imaging reports (same modality) for progression assessment; three laboratory test results; consultation notes from three clinical specialists; discharge summaries; AI-Generated summaries (three summaries of different quality), including:
- High quality summary: complete, well-structured, clinically relevant;
- Medium quality summary: partial omissions, acceptable structure;
- Low quality summary: significant omissions/poor structure.
Stage 4: Comparative analysis of open-license generative AI architectures.
Stage 5: Model selection according to pre-defined selection criteria.
Stage 6: Model adaptation (fine-tuning and prompt optimization).
Stage 7: Development and UMIAS integration of a minimum viable product (MVP).
Stage 8: Pilot Testing.
Participants: 27 radiologists divided into three groups (A, B and C; n=9 each). Detailed description of each group is in section 'Groups and Interventions'. The group B will evaluate AI-summary quality via specially developed and validated questionnaire (scores: ≤8=low, 9-15=medium, >15=high).
In the end of pilot testing primary and secondary outcomes will be assessed.
Stage 9: Comparative analysis across all groups. Formulation of conclusions and assessment of the AI-assistant's applicability.
- Keywords
- LLM, generative AI, radiologist workstation, Artificial Intelligence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Reviews full electronic medical record without AI summaries | Group A will review full electronic medical records without AI-generated summaries. Participants will be required to determine the purpose of the radiological examination and prepare a full radiology report (including protocol and conclusion). | |
| Group B: Evaluates AI summaries via validated questionnaire | Group B will receive access to full electronic medical records and to AI-generated summaries, which they will have to evaluate via specially developed and validated questionnaire. Participants will have to determine the purpose of the radiological examination, generate a complete radiology report (protocol + conclusion) and evaluate the AI summaries using a validated questionnaire. | |
| Group C: Receives AI summaries only | Group C participants will receive only AI-generated clinical summaries without access to full electronic medical records. Each radiologist in this group will be required to determine the purpose of the radiological examination and generate a complete radiology report consisting of both protocol documentation and diagnostic conclusion. Comparative analysis will be performed against Groups A and B for all measured outcome parameters. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiologist satisfaction levels
Radiologists' satisfaction levels with the AI-powered workstation will be measured using a specially developed questionnaire.
Measured: 6 months
Secondary outcomes (3)
Change in time required for medical record analysis
Measured change in time radiologist spend analyzing medical records during interpretation of radiological studies.
Measured: 6 months
Change in study interpretation time
Measurement of total time spent by a radiologist interpreting a single radiological examination when using an AI assistant
Measured: 6 months
Change in the number of reporting errors
Comparison of the number of reporting errors before and after AI assistant implementation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Study Aims to Develop and Validate a Generative AI-assistant Designed to Optimize Radiologists' Workflows and to Evaluate Its PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anton V. Vladzymyrskyy, Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
- Investigators
- Yuriy A. Vasilev, PhD, MD, Study director, Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057830
- Sponsor's protocol ID
- 2025-2
- Acronym
- GARW
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Borisov A, Burtsev T, Kosov P, Bobrovskaya T, Vasilev Y, Vladzymyrskyy A, Omelyanskaya O, Pamova A, Arzamasov K. Key aspects of fine-tuning and applying LLM-as-a-judge for clinical data summaries in the radiological workflow. Front Artif Intell. 2026 Mar 19;9:1768005. doi: 10.3389/frai.2026.1768005. eCollection 2026.
PubMed 41940108
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced AI-powered Workstation for Radiologists Based on Generative Artificial Intelligence
- ClinicalTrials.gov ID
- NCT07057830
- Acronym / sponsor ID
- GARW / 2025-2
- Keywords
- LLM, generative AI, radiologist workstation, Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care DepartmentUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to develop a generative AI assistant for radiologists to automate the processing of electronic medical records (EMRs) and provide relevant clinical information, optimizing diagnostic interpretation workflows.
Detailed description
This study aims to develop and validate a generative AI-assistant designed to optimize radiologists' workflow by automatically processing electronic medical records (EMRs) and generating structured clinical summaries. The AI tool will extract and prioritize relevant patient data to support accurate and efficient interpretation of diagnostic imaging studies.
The study rationale originates from increasing radiology workloads and the need to reduce time spent reviewing EMRs while maintaining diagnostic accuracy. The proposed AI solution specifically targets these issues through advanced natural language processing capabilities, with particular attention to optimizing time efficiency while maintaining or improving diagnostic accuracy.
The study consists of 9 Stages:
Stage 1: Theoretical Foundation.
1.1 Systematic review: comprehensive analysis of existing LLM applications in radiology.
1.2 Healthcare system analysis: evaluation of LLM implementations in clinical settings.
1.3 Expert consensus: semi-structured interviews with 30 practicing radiologists (stratified by experience: junior [<3 years], mid-career [3-10 years], senior [>10 years]) to establish:
- Minimum required clinical data elements;
- Optimal summary format (structured vs. narrative);
- Critical alert thresholds.
Stage 2: Technical Development.
2.1 Medical text processing: formalization of methods for extraction, standardization, and annotation.
2.2 Dataset Curation: methodology for creating representative training datasets from UMIAS (Unified Medical Information and Analytical System).
2.3 Validation Framework: creation of validation methodology for the generative AI-based assistant.
Development and validation of a questionnaire assessing:
- Relevance;
- Completeness (missing critical data);
- Hallucination frequency;
- Terminology/grammar;
- Radiologist satisfaction.
Stage 3: Dataset Development.
Data Source: Retrospective extraction of anonymized EMRs from UMIAS.
Inclusion Criteria:
- Age of the patient at the moment of medical image acquisition >18 years;
- Pathology types: pleuritis, ascites, unspecified masses/lesions, neuropathy;
- Imaging study modalities (performed between January 1, 2020, and May 31, 2025): CT chest (pleural/pulmonary pathologies); CT abdomen/pelvis (ascites/abdominal masses); MRI brain (neuropathy/neurological conditions);
- Complete EMR data (clinical notes, prior imaging reports, lab results, discharge summaries).
Exclusion Criteria:
Cases with technical artifacts on medical images compromising diagnostic quality.
Per-case data collected: physical examination results; two prior imaging reports (same modality) for progression assessment; three laboratory test results; consultation notes from three clinical specialists; discharge summaries; AI-Generated summaries (three summaries of different quality), including:
- High quality summary: complete, well-structured, clinically relevant;
- Medium quality summary: partial omissions, acceptable structure;
- Low quality summary: significant omissions/poor structure.
Stage 4: Comparative analysis of open-license generative AI architectures.
Stage 5: Model selection according to pre-defined selection criteria.
Stage 6: Model adaptation (fine-tuning and prompt optimization).
Stage 7: Development and UMIAS integration of a minimum viable product (MVP).
Stage 8: Pilot Testing.
Participants: 27 radiologists divided into three groups (A, B and C; n=9 each). Detailed description of each group is in section 'Groups and Interventions'. The group B will evaluate AI-summary quality via specially developed and validated questionnaire (scores: ≤8=low, 9-15=medium, >15=high).
In the end of pilot testing primary and secondary outcomes will be assessed.
Stage 9: Comparative analysis across all groups. Formulation of conclusions and assessment of the AI-assistant's applicability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Reviews full electronic medical record without AI summaries | – | –Group A will review full electronic medical records without AI-generated summaries. Participants will be required to determine the purpose of the radiological examination and prepare a full radiology report (including protocol and conclusion). |
| Group B: Evaluates AI summaries via validated questionnaire | – | –Group B will receive access to full electronic medical records and to AI-generated summaries, which they will have to evaluate via specially developed and validated questionnaire. Participants will have to determine the purpose of the radiological examination, generate a complete radiology report (protocol + conclusion) and evaluate the AI summaries using a validated questionnaire. |
| Group C: Receives AI summaries only | – | –Group C participants will receive only AI-generated clinical summaries without access to full electronic medical records. Each radiologist in this group will be required to determine the purpose of the radiological examination and generate a complete radiology report consisting of both protocol documentation and diagnostic conclusion. Comparative analysis will be performed against Groups A and B for all measured outcome parameters. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises 27 board-certified radiologists from tertiary hospitals, who have more than three years of working experience, proficiency in using UMIAS and no competing research involvement.
Key inclusion criteria (4 listed)
- Board-certified practicing radiologist;
- ≥3 years of experience in diagnostic imaging;
- Proficiency in using UMIAS systems;
- Signed informed consent form.
Key exclusion criteria (3 listed)
- Participation in other studies;
- Unwillingness to adopt new technologies in daily practice;
- Conflict of interest.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Radiologist satisfaction levels
Time frame: 6 months
Radiologists' satisfaction levels with the AI-powered workstation will be measured using a specially developed questionnaire.
3 secondary outcomes
Change in time required for medical record analysis
Time frame: 6 months
Change in study interpretation time
Time frame: 6 months
Change in the number of reporting errors
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Derived from this study: PubMed 41940108Borisov A, Burtsev T, Kosov P, Bobrovskaya T, Vasilev Y, Vladzymyrskyy A, Omelyanskaya O, Pamova A, Arzamasov K. Key aspects of fine-tuning and applying LLM-as-a-judge for clinical data summaries in the radiological workflow. Front Artif Intell. 2026 Mar 19;9:1768005. doi: 10.3389/frai.2026.1768005. eCollection 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuriy A. Vasilev, PhD, MD study director
Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Study Aims to Develop and Validate a Generative AI-assistant Designed to Optimize Radiologists' Workflows and to Evaluate Its Performance, run by Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department at 2 sites 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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anton V. Vladzymyrskyy, PhD, MD (+7 (495) 276-04-36, VladzimirskijAV@zdrav.mos.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiologist satisfaction levels (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07057830, which also lists 1 linked publication.
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 10 Jul 2025.