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

NCT06401434 | Completed

• 1 other identifier: EVALUATE
• Study Type: interventional
• Target: 23,835
• Locations: 1 country
• Sites: 3

Brief 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. 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. 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

Tuberculosis

Keywords

Tuberculosis (TB); AI-CAD software; Active case finding (ACF)

Outcome Measures

Primary Outcomes (1)

• Chest X-ray abnormality rate

  Difference in the proportion of chest X-ray images which are declared as abnormal by the on-site radiologist between the study arms

  Within 30 minutes of chest X-ray capture

Secondary Outcomes (1)

• TB detection rate

  Xpert MTB/RIF Ultra test result within 30 days after a chest X-ray screen

Study Arms (2)

On-site radiologist

ACTIVE COMPARATOR

On-site radiologist reads/interprets all CXR images

Diagnostic Test: On-site radiologist

CAD-based triage (with INSIGHT CXR software)

EXPERIMENTAL

CAD software processes all CXR images and the on-site radiologist only reads/interprets the subset not deemed totally to be clear/normal by the CAD software

Diagnostic Test: CAD-based triage (with INSIGHT CXR software)

Interventions

On-site radiologist DIAGNOSTIC_TEST

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.

On-site radiologist

CAD-based triage (with INSIGHT CXR software) DIAGNOSTIC_TEST

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.

CAD-based triage (with INSIGHT CXR software)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Recently received a TB diagnosed (not yet on treatment)
• Currently being treated for TB
• Pregnant women

Sponsors & Collaborators

• Freundeskreis Für Internationale Tuberkulosehilfe e.V: lead

Study Sites (3)

Pham Ngoc Thach Hospital

Ho Chi Minh City, Vietnam

Location

Long An Lung Hospital

Long An, Vietnam

Location

Pham Huu Chi Lung Hospital, BR-VT

Vũng Tàu, Vietnam

Location

Related Publications (6)

• WHO consolidated guidelines on tuberculosis: Module 2: screening - systematic screening for tuberculosis disease [Internet]. Geneva: World Health Organization; 2021. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK569338/

  PMID: 33822560 BACKGROUND

• Potnis KC, Ross JS, Aneja S, Gross CP, Richman IB. Artificial Intelligence in Breast Cancer Screening: Evaluation of FDA Device Regulation and Future Recommendations. JAMA Intern Med. 2022 Dec 1;182(12):1306-1312. doi: 10.1001/jamainternmed.2022.4969.

  PMID: 36342705 BACKGROUND

• Twilt JJ, van Leeuwen KG, Huisman HJ, Futterer JJ, de Rooij M. Artificial Intelligence Based Algorithms for Prostate Cancer Classification and Detection on Magnetic Resonance Imaging: A Narrative Review. Diagnostics (Basel). 2021 May 26;11(6):959. doi: 10.3390/diagnostics11060959.

  PMID: 34073627 BACKGROUND

• Milam ME, Koo CW. The current status and future of FDA-approved artificial intelligence tools in chest radiology in the United States. Clin Radiol. 2023 Feb;78(2):115-122. doi: 10.1016/j.crad.2022.08.135. Epub 2022 Sep 28.

  PMID: 36180271 BACKGROUND

• Vo LNQ, Forse RJ, Codlin AJ, Vu TN, Le GT, Do GC, Van Truong V, Dang HM, Nguyen LH, Nguyen HB, Nguyen NV, Levy J, Squire B, Lonnroth K, Caws M. A comparative impact evaluation of two human resource models for community-based active tuberculosis case finding in Ho Chi Minh City, Viet Nam. BMC Public Health. 2020 Jun 15;20(1):934. doi: 10.1186/s12889-020-09042-4.

  PMID: 32539700 BACKGROUND

• Nguyen LH, Codlin AJ, Vo LNQ, Dao T, Tran D, Forse RJ, Vu TN, Le GT, Luu T, Do GC, Truong VV, Minh HDT, Nguyen HH, Creswell J, Caws M, Nguyen HB, Nguyen NV. An Evaluation of Programmatic Community-Based Chest X-ray Screening for Tuberculosis in Ho Chi Minh City, Vietnam. Trop Med Infect Dis. 2020 Dec 10;5(4):185. doi: 10.3390/tropicalmed5040185.

  PMID: 33321696 BACKGROUND

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Andrew J Codlin

  Freundeskreis Für Internationale Tuberkulosehilfe e.V

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 6, 2024
• Study Start: May 29, 2024
• Primary Completion: April 20, 2025
• Study Completion: April 20, 2025
• Last Updated: August 12, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

VN (3)