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COMPLETED
NCT07712952

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

Sponsor: Chung-Ang University Hospital

View on ClinicalTrials.gov

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.

Official title: Retrospective Evaluation of AI-Based Early Detection of Reticular Opacity in Longitudinal Chest Radiograph Sequences in Patients With Idiopathic Pulmonary Fibrosis

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

OBSERVATIONAL

Enrollment

175

Start Date

2025-04-30

Completion Date

2025-04-30

Last Updated

2026-07-20

Healthy Volunteers

No

Interventions

DEVICE

VUNO Med-Chest X-ray

Retrospective, offline application of the AI-based chest radiograph analysis software VUNO Med-Chest X-ray (VUNO Inc., Seoul, Korea) to archival chest radiographs obtained before each patient's IPF diagnosis. The software outputs scores for interstitial opacity(reticular opacity), consolidation, and nodule/mass; interstitial opacity(reticular opacity) score, applying a pre-specified cutoff, is used for the primary and secondary analyses. The AI analysis is performed solely for research purposes and does not inform clinical care.

Locations (1)

Chung-Ang University Hospital

Seoul, South Korea