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

NCT06401434 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23835

Last updated 2025-08-12

No results posted yet for this study

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

Conditions

Interventions

DIAGNOSTIC_TEST

On-site radiologist

All participants in this arm will be screened by CXR. All CXR images will be interpreted by only an on-site radiologist. Participants with an abnormal CXR result from the radiologist will be indicated for follow-on diagnostic testing with the Xpert MTB/RIF Ultra assay.

DIAGNOSTIC_TEST

CAD-based triage (with INSIGHT CXR software)

All participants in this arm will be screened by CXR. All CXR images will first be processed with the INSIGHT CXR CAD software (Lunit, South Korea) to identify the totally normal/clear CXR images; only those with the possibility of containing an abnormality (abnormality score ≥ 20) will be sent to the on-site radiologist for reading/interpretation. Participants with an abnormal CXR result from the radiologist will be indicated for follow-on diagnostic testing with the Xpert MTB/RIF Ultra assay.

Sponsors & Collaborators

  • Freundeskreis Für Internationale Tuberkulosehilfe e.V

    lead OTHER

Principal Investigators

  • Andrew J Codlin · Freundeskreis Für Internationale Tuberkulosehilfe e.V

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-29
Primary Completion
2025-04-20
Completion
2025-04-20

Countries

  • Vietnam

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 NCT06401434 on ClinicalTrials.gov