COVID-19 Volumetric Quantification on Computer Tomography Using Computer Aided Diagnostics

Not Applicable

Completed

• Conditions: COVID-19
• Interventions: Diagnostic Test: CAD analysis

• Registration Number: NCT05282056
• Lead Sponsor: Bogdan Bercean

Brief Summary

The aim of the study is to asses the influence of computer aided diagnostic to the process of lung affection quantification on computer tomography in COVID-19 confirmed patients.

Detailed Description

The lung involvement of COVID-19 patients has been showed to be correlated to clinical outcomes and became part of the clinical practice. Even though various scores can be used, the affection estimation is usually done on computer tomography, using radiologists's estimation skills which is a highly subjective process.

Artificial intelligence is a known objective constant and therefore a potential radiologist complement. This trial aims at studying the effect of using a computer aided diagnostic software integrated in the normal clinical practice of radiologists from Timisoara County Emergency Hospital. It uses the AI-PROBE analysis setup, which turns off the CAD outputs for randomly chosen 50% the cases (control) and then compares the radiological reports for differences between the two arms.

Study Timeline

• Study Start: 2022-02-24
• Study First Submitted: 2022-03-14
• Study First Submitted QC: 2022-03-14
• Primary Completion: 2022-03-15
• Study Completion: 2022-03-15
• Study First Posted: 2022-03-16
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• RT-PCR confirmed patients of COVID-19

Exclusion Criteria

• 15 or lower

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAD analysis	CAD analysis	The XVision COVID-19 computer aided diagnostic software is used by radiologist at CT analysis time

Primary Outcome Measures

Name	Time	Method
Mean difference of lung affection quantification percentage	At CT acquisition time, up to 2 weeks	The objective measurement of lung affection percentage is measured against pixel level labels. A lower difference mean better outcome.

Trial Locations

Locations (1)

Pius Brinzeu Timisoara County Emergency Hospital; 🇷🇴 Timisoara, Timis, Romania