Clinical Trial

Validation of AI-Based Detection of Idiopathic Pulmonary Fibrosis in Serial Chest Radiographs: A Retrospective Longitudinal Study

Completed
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Summary
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive fibrotic lung disease of unknown cause with a median survival of only 3-5 years after diagnosis. Early detection and timely initiation of antifibrotic therapy may improve outcomes, but diagnosis is frequently delayed. Chest radiography (CXR) is widely accessible and cost-effective but has limited sensitivity for early interstitial opacity (IO), so radiologists may miss or delay documentation of relevant findings. This retrospective, single-center, observational cohort study evaluates whether an artificial-intelligence algorithm (VUNO Med-Chest X-ray) can detect interstitial opacity earlier than radiologists in the historical chest radiograph series of patients who were diagnosed with IPF. The cohort was identified via a April 2025 registry screening of patients carrying an IPF diagnosis at Chung-Ang University Hospital. For each patient, the date of the first AI-detected IO (using a pre-specified score cutoff) is compared with the date of the first radiologist-reported mention of interstitial/reticular opacity, across all chest radiographs obtained before the IPF diagnosis date, within a 15-year retrospective imaging window anchored to the April 2025 screening date (January 2010-April 2025). The study also explores patient characteristics that modify this lead-time difference and whether longitudinal AI IO-score trajectories are associated with mortality.
Trial Details
NCT Number NCT07712952
Lead Sponsor Chung-Ang University Hospital
Collaborators: VUNO Inc.
Conditions Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease
Enrollment 175 participants
Start Date 2025-04-30
Primary Completion 2025-04-30 (estimated)
Study Completion 2025-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-20