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)