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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
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.

Anton V. Vladzymyrskyy, PhD, MD contact

+7 (495) 276-04-36

VladzimirskijAV@zdrav.mos.ru

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

Other trials in Russia

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 groups in NCT07057830
Study groupRoleWhat they receive
Group A: Reviews full electronic medical record without AI summariesGroup 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 questionnaireGroup 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 onlyGroup 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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted10 Jul 2025
  2. Study start1 Jul 2025 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion1 Feb 2026 (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
Cohort
Time perspective
Prospective
Enrolment
27 participants (estimated)
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

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.

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