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
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pham Ngoc Thach Hospital Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Unknown status |
| Long An Lung Hospital Coordinator of this site? Confirm its status | Long An | Vietnam | Unknown status |
| Pham Huu Chi Lung Hospital, BR-VT Coordinator of this site? Confirm its status | Vũng Tàu | Vietnam | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.