Viewing Study NCT06401434



Ignite Creation Date: 2024-05-11 @ 8:31 AM
Last Modification Date: 2024-10-26 @ 3:28 PM
Study NCT ID: NCT06401434
Status: RECRUITING
Last Update Posted: 2024-05-06
First Post: 2024-05-02

Brief Title: Evaluation of CAD-based Triage for CXR Interpretation During TB Screening
Sponsor: Freundeskreis Für Internationale Tuberkulosehilfe eV
Organization: Freundeskreis Für Internationale Tuberkulosehilfe eV

Study Overview

Official Title: EVALUATE Estimating the Value-Add of Lunit Softwares Use to Accelerate TB Elimination
Status: RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 andor efficiency may prove to be a more acceptable use case than outright radiologist replacement

Freundeskreis Für Internationale Tuberkulosehilfe eV 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 MTBRIF Ultra assay among those screened by chest X-ray between the study arms
Detailed Description: In 2021 the World Health Organization released guidelines which recommended computer-aided detection CAD software as a replacement for radiologists during chest X-ray CXR screening for TB1 However clinical workflows which position CAD software as a decision support tool for radiologists with the aim of improving CXR interpretation accuracy andor efficiency may prove to be a more acceptable use case with radiologists CAD software are now being integrated into breast 2 prostate 3 and lung 4 cancer screening programs in high-income countries in these ways Yet there is currently a dearth of literature evaluating CAD software during CXR screening for TB under such use cases

Freundeskreis Für Internationale Tuberkulosehilfe eV FIT in collaboration with local public-sector partners will organize 80 community-based CXR screening events for TB 56 across three provinces in Southern Viet Nam Ba Ria - Vung Tau Ho Chi Minh City and Long An 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

A retrospective assessment of comparing radiologist only CXR interpretation to CAD-based triage with INSIGHT CXR software showed that CAD-based triage resutled in a -689 reduction in human workloads a -301 decrease in CXR abnormality rates and follow-on diagnostic testing and just a -02 reduction in TB detection This pragmatic clinical trial is neseted within a community-based CXR screening initiative whose scale has been determined by the availability of donor funding However a sufficient number of participants will be recruited and screened in each arm to detect a 30 difference 124 vs 178 in the proportion of CXR images labelled as abnormal primary aim

Study Arms

1 On-site radiologist usual care 40 screening events 12000 participants 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 diagnostic testing
2 CAD-based triage experimental care 40 screening events 12000 participants 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 normalclear CXR images only those with the possibility of containing an abnormality abnormality score 20 will be sent to the on-site radiologist Participants with an abnormal CXR result from the radiologist will be indicated for diagnostic testing

Aims

1 Compare the difference in the proportion of CXR 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 MTBRIF Ultra assay among those screened by CXR between the study arms

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None