TuberculosisNCT06401434
Evaluation of CAD-based Triage for CXR Interpretation During TB Screening
A study testing On-site radiologist and CAD-based triage (with INSIGHT CXR software) in people with Tuberculosis, run by Freundeskreis Für Internationale Tuberkulosehilfe e.V at 3 sites in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- On-site radiologist and CAD-based triage (with INSIGHT CXR software)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23,835 participants
- Where
- 3 sitesVietnam
- Study dates
- 29 May 2024to 20 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing to be screened for TB
- Aged ≥ 18 years
Who cannot join
- Recently received a TB diagnosed (not yet on treatment)
- Currently being treated for TB
- Pregnant women
Trial locations and contacts
3 sites in 1 country.
Vietnam3 sites
Pham Ngoc Thach Hospital
Ho Chi Minh City
Long An Lung Hospital
Long An
Pham Huu Chi Lung Hospital, BR-VT
Vũng Tàu
About this study
Official title: EVALUATE: Estimating the Value-Add of Lunit Software's Use to Accelerate TB Elimination
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).
Read more
Aims
- 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
- 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
Read the 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 TB.[1] However, clinical workflows which position CAD software as a decision support tool for radiologists, with the aim of improving CXR interpretation accuracy and/or 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 e.V. (FIT), in collaboration with local public-sector partners, will organize 80 community-based CXR screening events for TB [5,6] 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 -68.9% reduction in human workloads, a -30.1% decrease in CXR abnormality rates and follow-on diagnostic testing, and just a -0.2% 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 (12.4% vs 17.8%) in the proportion of CXR images labelled as abnormal (primary aim).
Study Arms
- On-site radiologist / usual care (40 screening events; 12,000 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.
- CAD-based triage / experimental care (40 screening events; 12,000 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 normal/clear 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
- Compare the difference in the proportion of CXR images which are declared as abnormal by the on-site radiologist between the study arms
- Compare the difference in the proportion of people diagnosed with TB using the Xpert MTB/RIF Ultra assay among those screened by CXR between the study arms
- Conditions
- Tuberculosis
- Being tested
- On-site radiologist, CAD-based triage (with INSIGHT CXR software)
- Keywords
- Tuberculosis (TB), AI-CAD software, Active case finding (ACF)
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-site radiologistDiagnostic 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| On-site radiologist | Active comparator | On-site radiologist reads/interprets all CXR images Receives: 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 Receives: Diagnostic Test: CAD-based triage (with INSIGHT CXR software) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 30 minutes of chest X-ray capture
Secondary outcomes (1)
TB detection rate
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
Measured: Xpert MTB/RIF Ultra test result within 30 days after a chest X-ray screen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start29 May 2024
- Primary completion20 Apr 2025
- Study completion20 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23,835 participants (actual)
Sponsor and investigators
- Lead sponsor
- Freundeskreis Für Internationale Tuberkulosehilfe e.V
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew J Codlin, Principal investigator, Freundeskreis Für Internationale Tuberkulosehilfe e.V
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401434
- Sponsor's protocol ID
- EVALUATE
- Status last verified
- Sep 2024
- First submitted
- 2 May 2024
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared outside of the sponsoring organization
Publications
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/
PubMed 33822560Potnis 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.
PubMed 36342705Twilt 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.
PubMed 34073627Milam 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.
PubMed 36180271Vo 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.
PubMed 32539700Nguyen 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.
PubMed 33321696
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATE: Estimating the Value-Add of Lunit Software's Use to Accelerate TB Elimination
- ClinicalTrials.gov ID
- NCT06401434
- Acronym / sponsor ID
- EVALUATE
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis (TB), AI-CAD software, Active case finding (ACF)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23,835 participants (actual)
- Lead sponsor
- Freundeskreis Für Internationale Tuberkulosehilfe e.VUniversity, hospital or other
- Study start
- 29 May 2024 (actual)
- Primary completion
- 20 Apr 2025 (actual)
- Study completion
- 20 Apr 2025 (actual)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- 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
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 TB.[1] However, clinical workflows which position CAD software as a decision support tool for radiologists, with the aim of improving CXR interpretation accuracy and/or 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 e.V. (FIT), in collaboration with local public-sector partners, will organize 80 community-based CXR screening events for TB [5,6] 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 -68.9% reduction in human workloads, a -30.1% decrease in CXR abnormality rates and follow-on diagnostic testing, and just a -0.2% 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 (12.4% vs 17.8%) in the proportion of CXR images labelled as abnormal (primary aim).
Study Arms
- On-site radiologist / usual care (40 screening events; 12,000 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.
- CAD-based triage / experimental care (40 screening events; 12,000 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 normal/clear 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
- Compare the difference in the proportion of CXR images which are declared as abnormal by the on-site radiologist between the study arms
- Compare the difference in the proportion of people diagnosed with TB using the Xpert MTB/RIF Ultra assay among those screened by CXR between the study arms
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| On-site radiologist | Active comparator | Diagnostic Test: On-site radiologistOn-site radiologist reads/interprets all CXR images |
| CAD-based triage (with INSIGHT CXR software) | Experimental | Diagnostic Test: CAD-based triage (with INSIGHT CXR software)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Willing to be screened for TB
- Aged ≥ 18 years
Key exclusion criteria (3 listed)
- Recently received a TB diagnosed (not yet on treatment)
- Currently being treated for TB
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| On-site radiologistAll 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 | On-site radiologist |
| 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. | Diagnostic test | CAD-based triage (with INSIGHT CXR software) |
Primary outcome
Chest X-ray abnormality rate
Time frame: Within 30 minutes of chest X-ray capture
Difference in the proportion of chest X-ray images which are declared as abnormal by the on-site radiologist between the study arms
1 secondary outcome
TB detection rate
Time frame: Xpert MTB/RIF Ultra test result within 30 days after a chest X-ray screen
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Background: PubMed 33822560WHO 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/
- Background: PubMed 36342705Potnis 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.
- Background: PubMed 34073627Twilt 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.
- Background: PubMed 36180271Milam 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.
- Background: PubMed 32539700Vo 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.
- Background: PubMed 33321696Nguyen 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared outside of the sponsoring organization
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew J Codlin principal investigator
Freundeskreis Für Internationale Tuberkulosehilfe e.V
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On-site radiologist and CAD-based triage (with INSIGHT CXR software) in people with Tuberculosis, run by Freundeskreis Für Internationale Tuberkulosehilfe e.V at 3 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest X-ray abnormality rate (time frame: Within 30 minutes of chest X-ray capture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06401434, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.