AI-based System for Assessing Suspected Viral Pneumonia Related Lung Changes

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorResearch and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department

About this trial

The AI-based system designed to process chest computed tomography (CT) aims to 1) detect the presence of pathologic patterns associated with interstitial changes in pneumonia; 2) highlight areas on the images with the probable presence of pathologies; 3) provide the physician with the results of image processing, including quantitative indicators of suspected viral pneumonia related lung changes according to visual pulmonary lesion grading system (CT0-4).

The retrospective study aims to demonstrate the clinical validation of the AI-based system. Clinical validation measures (sensitivity, specificity, accuracy, and area under the ROC curve) will be determined to provide evidence about the clinical efficacy of the AI-based system.

The hypothesis is that the measures of clinical validation of the AI-based system differ by no more than 8% from those declared by the manufacturer.

Eligibility criteria

Qualifiers

General

Patients over 18 years old;

Patients who underwent CT without contrast enhancement;

Patients who underwent a CT scan according to a standardized scanning protocol: 120 kilovolts, slice thickness max. 2 mm, rigid "lung" filter (kernel) reconstruction;

Disqualifiers

Patients whose studies contain images with unreported CT patterns;

Patients whose examinations do not conform to DICOM format;

Patients whose examinations do not contain imaging of the lung region

Patients whose examinations contain technical artifacts caused by malfunctions or features of CT scanners;

Trial design

Treatments tested in this trial

  • Medical software (AI-based system)

Treatment groups

563 Participants
are divided into 5 treatment groups

Locations

1
Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department127051, Moscow Russia

Sponsors and collaborators

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

Lead sponsor

Sciberia Co. Ltd

Collaborator