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NCT06401434Completed

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

Source: ClinicalTrials.gov · Last updated 12 Aug 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Interventional
Enrollment
23835 (actual)
First submitted
2 May 2024
Start date
May 2024
Primary completion date
Apr 2025
Lead sponsor
Freundeskreis Für Internationale Tuberkulosehilfe e.V
Diseases
Tuberculosis
NCT number
NCT06401434

What you commit to

  • Study type: Interventional
  • Participants enrolled: 23835
  • From May 2024 to the primary completion date, Apr 2025
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Recently received a TB diagnosed (not yet on treatment)

Other

  • Currently being treated for TB
  • Pregnant women

Who the study is looking for

  • Willing to be screened for TB
  • Aged ≥ 18 years

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Pham Ngoc Thach Hospital
Coordinator of this site? Confirm its status
Ho Chi Minh CityVietnamUnknown status
Long An Lung Hospital
Coordinator of this site? Confirm its status
Long AnVietnamUnknown status
Pham Huu Chi Lung Hospital, BR-VT
Coordinator of this site? Confirm its status
Vũng TàuVietnamUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.