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Generative AI Radiologist's Workstation

Observational Study Aims to Develop and Validate a Generative AI-assistant Designed to Optimize Radiologists' Workflows and to Evaluate Its Performance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Study Aims to Develop and Validate a Generative AI-assistant Designed to Optimize Radiologists' Workflows and to Evaluate Its Performance. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Radiologist satisfaction levels [Time frame: 6 months]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Russia · 2 centers
  • MIREA - Russian Technological University — Moscow
  • Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of th — Moscow

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. PMID 41940108

Identifiers

NCT: NCT07057830 · 2025-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗