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