Evaluation of CAD-based Triage for CXR Interpretation During TB Screening - Trial NCT06401434

Timeline & Enrollment

Primary Outcome

Chest X-ray abnormality rate

Summary

Clinical workflows which position computer-aided detection (CAD) software for chest X-ray
 interpretation during TB screening as a decision support tool for radiologists, with the aim
 of improving interpretation accuracy and/or efficiency, may prove to be a more acceptable use
 case than outright radiologist replacement.
 
 Freundeskreis Für Internationale Tuberkulosehilfe e.V. (FIT) will organize 80 community-based
 chest X-ray screening events for TB across three provinces of Viet Nam as part of a pragmatic
 clinical trial designed to assess the real-world impact a CAD software deployment. INSIGHT
 CXR CAD software (Lunit, South Korea) will be used to support CXR interprtation at half of
 the screening events (randomly selected) by automating the identification of normal CXR
 images before an on-site radiologist makes a final CXR interpretation (CAD-based triage use
 case). The other screening events will use only an on-site radiologist for CXR interpretation
 (usual care).
 
 Aims
 
 1. Compare the difference in the proportion of chest X-ray images which are declared as
 abnormal by the on-site radiologist between the study arms
 
 2. Compare the difference in the proportion of people diagnosed with TB using the Xpert
 MTB/RIF Ultra assay among those screened by chest X-ray between the study arms

ICD-10 Classifications