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

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

Status: Active, not recruiting

Conditions: Tuberculosis, Pulmonary

Treatments: Diagnostic Test: AI-based x-ray analysis and triage ("normal/tuberculosis suspected")

Study type: Observational

Funder types: Other

Identifiers

NCT05889364

2018-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 308 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

308 participants in 2 patient groups

Sample N1

Description:

(n=140) with ratio "normal: tuberculosis" 50:50

Treatment:

Diagnostic Test: AI-based x-ray analysis and triage ("normal/tuberculosis suspected")

Sample N2

Description:

(n=150) with ratio "normal: tuberculosis" 95:5

Treatment:

Diagnostic Test: AI-based x-ray analysis and triage ("normal/tuberculosis suspected")