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NCT Number: NCT07057830

Generative AI Radiologist's Workstation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MIREA - Russian Technological University, Moscow, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Board-certified practicing radiologist;
  • ≥3 years of experience in diagnostic imaging;
  • Proficiency in using UMIAS systems;
  • Signed informed consent form.

Exclusion criteria

  • Participation in other studies;
  • Unwillingness to adopt new technologies in daily practice;
  • Conflict of interest.

Treatment and study plan

Primary outcomes

  1. Radiologist satisfaction levels

    Time frame: 6 months

    Radiologists' satisfaction levels with the AI-powered workstation will be measured using a specially developed questionnaire.

Secondary outcomes

  1. Change in time required for medical record analysis

    Time frame: 6 months

    Measured change in time radiologist spend analyzing medical records during interpretation of radiological studies.

  2. Change in study interpretation time

    Time frame: 6 months

    Measurement of total time spent by a radiologist interpreting a single radiological examination when using an AI assistant

  3. Change in the number of reporting errors

    Time frame: 6 months

    Comparison of the number of reporting errors before and after AI assistant implementation

Study contacts

Contact information is provided by the study sponsor or research team.

Anton V. Vladzymyrskyy, PhD, MD

CONTACT

[email protected]

+7 (495) 276-04-36

Sponsors and collaborators

Lead sponsor

Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department

Other

Registry information

Official study title

Advanced AI-powered Workstation for Radiologists Based on Generative Artificial Intelligence

Acronym: GARW

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 10, 2025
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.