Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT06501599

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

Led by Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department · Updated on 2024-07-22

563

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

Sponsors

R

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

Lead Sponsor

S

Sciberia Co. Ltd

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over 18 years old
  • Patients who had a chest CT scan without contrast enhancement
  • Chest CT scans performed with 120 kilovolts, slice thickness up to 2 mm, and rigid "lung" filter reconstruction
  • Chest CT images of acceptable quality without technical, respiratory, or movement artifacts
  • Chest CT images containing DICOM tags for patient orientation, position, scan size, and image parameters
  • Lung changes mainly bilateral in basal and subpleural areas, possibly peribronchial
  • For normal group: no COVID-19-related CT patterns
  • For mild, moderate, severe, and critical groups: presence of COVID-19-related CT patterns such as ground glass opacities, pulmonary consolidation, cobblestone infiltration, hydrothorax, or combinations thereof
Not Eligible

You will not qualify if you...

  • Studies containing images with unreported CT patterns
  • Examinations not in DICOM format
  • Examinations missing lung region imaging
  • Examinations with technical artifacts from scanner malfunctions
  • Examinations with improper patient positioning
  • Examinations missing DICOM tags for scan size and image parameters
  • Examinations with metal artifacts on patient or clothing
  • Presence of other lung diseases like neoplasms, tuberculosis, or bacterial pneumonia
  • Patients under 18 years old

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Moscow, Russia, 127051

Actively Recruiting

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Research Team

V

Victoria Zinchenko

CONTACT

A

Anton Vladzymyrskyy

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

5

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