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

NCT ID: NCT05889364

Last Updated: 2023-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

308 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-01

Study Completion Date

2023-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Tuberculosis, Pulmonary

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Sample N1

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

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

Intervention Type DIAGNOSTIC_TEST

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).

Sample N2

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

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

Intervention Type DIAGNOSTIC_TEST

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).

Interventions

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AI-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).

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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artificial intelligence analysis of medical images

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Anton V. Vladzymyrskyy

Deputy CEO

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anton Vladzymyrskyy

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Research and Practical Center of Medical Radiology, Department of Health Care of Moscow

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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2018-1

Identifier Type: -

Identifier Source: org_study_id

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