Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

July 10, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

June 30, 2025

Last Update Submit

June 30, 2025

Conditions

Keywords

LLM, generative AI, radiologist workstation, Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

  • Radiologist satisfaction levels

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

    6 months

Secondary Outcomes (3)

  • Change in time required for medical record analysis

    6 months

  • Change in study interpretation time

    6 months

  • Change in the number of reporting errors

    6 months

Study Arms (3)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

MIREA - Russian Technological University

Moscow, 119454, Russia

Location

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

Moscow, 127051, Russia

Location

Study Officials

  • Yuriy A. Vasilev, PhD, MD

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

    STUDY DIRECTOR

Central Study Contacts

Anton V. Vladzymyrskyy, PhD, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director for Research

Study Record Dates

First Submitted

June 30, 2025

First Posted

July 10, 2025

Study Start

July 1, 2025

Primary Completion

December 31, 2025

Study Completion

February 1, 2026

Last Updated

July 10, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations