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

This trial accepts healthy volunteers

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 population

Adults (patients over 18 years of age) who were referred for a chest CT study by a physician in case of suspicion or monitoring the effectiveness of treatment of diseases manifested by changes in the pulmonary parenchyma.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Medical software (AI-based system)

    Diagnostic test

    Retrospective analysis of chest CT images with medical software (AI-based system)

Treatment groups

563 Participants
are divided into 5 treatment groups
Group A: Normal1 intervention
Group B: Mild1 intervention
Group C: Moderate1 intervention
Group D: Severe1 intervention
Group E: Critical1 intervention

Trial outcomes

Primary outcomes

1

Accuracy

The ability of an AI-based system to produce the correct result relative to the total number of trials

Time frame
Upon completion, up to 1 year
2

Sensitivity

Effectiveness of the AI-based system to correctly identifies patients with the suspected viral pneumonia related lung changes

Time frame
Upon completion, up to 1 year
3

Specificity

Effectiveness of the AI-based system to correctly identifies across a range of available measurements patients that do not have the suspected viral pneumonia related lung changes

Time frame
Upon completion, up to 1 year
4

AUC ROC

The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of AI-based system in prediction of suspected viral pneumonia related lung changes

Time frame
Upon completion, up to 1 year

Secondary outcomes

1

Approximate volume of affected lung tissue

Approximate volume of affected lung tissue - quantitative characteristics of lung damage volume in percent (%): separately for left lung, right lung and total percentage of damage

Time frame
Time Frame: Upon completion, up to 1 year

Other outcomes

Sponsors and contacts

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