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Change in the Proportion of Correct Interpretations of Pulmonary Opacities

NCT07744555 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-04

No results posted yet for this study

Summary

This randomized crossover clinical trial will evaluate whether an artificial intelligence-based expert system improves the interpretation of chest radiographs by final-year medical students, rural physicians, and general practitioners with less than two years of clinical experience.

Participants will interpret chest radiographs containing normal findings or pulmonary opacities classified as alveolar, interstitial, or mixed. Each participant will review the same set of radiographs twice: once without assistance from the expert system and once with assistance from the artificial intelligence system. The order of these two reading conditions will be randomly assigned, with a six-week interval between sessions to reduce memory effects.

The main outcome will be the proportion of correct interpretations compared with a previously established reference standard based on radiologist interpretation supported by chest computed tomography findings. The study will also assess diagnostic confidence and agreement with the reference standard.

This study does not involve treatment decisions or direct patient care. It is intended to determine whether artificial intelligence support may improve the accuracy and confidence of less-experienced physicians when interpreting pulmonary opacities on chest radiographs.

Conditions

Interventions

DEVICE

Artificial intelligence expert system

Artificial intelligence-based expert system for computer-aided interpretation of chest radiographs. The system is an open-source deep-learning model that analyzes posteroanterior chest radiographs and reports the presence of pulmonary opacities. During the intervention phase, each participant interprets the same set of chest radiographs while the output of the expert system is displayed together with each image. Participants remain responsible for the final interpretation and record it on the study data form. The expert system is used only as a reading aid for study participants; it is not used for clinical care, and no diagnostic, treatment, or management decision for any patient is based on its output.

Sponsors & Collaborators

  • Universidad de la Sabana

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2026-10-31
Completion
2026-12-31

Countries

  • Colombia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07744555 on ClinicalTrials.gov