NCT06401434

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

EVALUATE: Estimating the Value-Add of Lunit Software's Use to Accelerate TB Elimination
Freundeskreis Für Internationale Tuberkulosehilfe e.V·ClinicalTrials.gov·diagnostic testNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Tuberculosis
Drug/Device/Intervention
On-site radiologist
Study type
Interventional
Intervention type
diagnostic test
Sponsor & location
Primary sponsor
Freundeskreis Für Internationale Tuberkulosehilfe e.V
Location
Ho Chi Minh City,Long An,Vung Tau, Vietnam
Timeline & enrollment
Phase
N/A
Start date
Jun 01, 2024
End date
Dec 01, 2024
Enrollment
24000 participants
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
TuberculosisLatent tuberculosisTuberculosis of other organsCongenital tuberculosisSequelae of tuberculosis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06401434
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06401434 through Pure Global AI's free database. This phase not specified trial is sponsored by Freundeskreis Für Internationale Tuberkulosehilfe e.V and is currently Not yet recruiting. The study focuses on Tuberculosis. Target enrollment is 24000 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.