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AI-based System for Lung Tuberculosis Screening: Diagnostic Accuracy Evaluation

AI-based System for Lung Tuberculosis Screening: Diagnostic Accuracy Evaluation

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05889364
Enrollment
308
Registered
2023-06-05
Start date
2018-02-01
Completion date
2023-12-30
Last updated
2023-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis, Pulmonary

Keywords

AI, deep learning, tuberculosis, radiology, x-ray, e-health, screening, chest, artificial intelligence

Brief summary

Testing of AI solutions to assess diagnostic accuracy for tuberculosis detection.

Detailed description

Tuberculosis remains a key problem of modern medicine. New approaches for burden overcoming should be proposed. New screening strategies may include artificial intelligence (AI). An AI-based system for chest x-ray analysis and triage (normal/tuberculosis suspected) have been developed and trained. A special data-set was prepared. There are 238 normal x-rays and 70 x-rays with lung tuberculosis in data-set. The data-set was randomly divided into 2 samples: * sample N1 (n=140) with ratio normal: tuberculosis 50:50, * sample N1 (n=150) with ratio normal: tuberculosis 95:5. Both samples will be analysed by AI-based system. Results will be quantified using diagnostic accuracy metrics: sensitivity and specificity, positive and negative predictor values, likelihood ratio, and area under the ROC (receiver operating characteristic) curve.

Interventions

DIAGNOSTIC_TESTAI-based x-ray analysis and triage (normal/tuberculosis suspected)

All included x-rays will be analysed by the AI-based system. Then results will be compared with opinions of 2 experienced radiologists (they make peer-review of all included images independently of each other).

Sponsors

Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

Inclusion criteria

* no pathology in a lung on chest x-ray * signs of lung tuberculosis on chest x-ray

Exclusion criteria

* any pathology in the lungs (except tuberculosis)

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy metric 1Day 1 upon receipt of dataSensitivity
Diagnostic accuracy metric 2Day 2 upon receipt of dataSpecificity
Diagnostic accuracy metric 3Day 3 upon receipt of dataPositive predictor values
Diagnostic accuracy metric 4Day 4 upon receipt of dataNegative predictor values
Diagnostic accuracy metric 5Day 5 upon receipt of dataLikelihood ratio
Diagnostic accuracy metric 6Day 6 upon receipt of dataArea under the ROC curve

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026