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

Sponsor

Bogdan Bercean (Industry)

Overall Status

Completed

CT.gov ID

NCT05282056

Collaborator

Pius Brinzeu Timisoara County Emergency Hospital (Other)

200

Enrollment

Location

Arms

Actual Duration (Days)

320.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Diagnostic Test: CAD analysis	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

CAD outputs are turned off for randomly chosen 50% of patients, which represent the control group. The other 50% are analysed using CADCAD outputs are turned off for randomly chosen 50% of patients, which represent the control group. The other 50% are analysed using CAD

Masking:

Single (Participant)

Masking Description:

The random assignment is done automatically by the CAD system and is not visible to the patient. The radiologist obviously sees which cases have CAD analysis and which not.

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Feb 24, 2022

Actual Primary Completion Date :

Mar 15, 2022

Actual Study Completion Date :

Mar 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CAD analysis The XVision COVID-19 computer aided diagnostic software is used by radiologist at CT analysis time	Diagnostic Test: CAD analysis CAD shows the radiologist automatically delineated areas of potential COVID-19 affection, together with an overall lung affection percentage.
No Intervention: No CAD analysis No CAD analysis is shown to radiologist.

Arm

Intervention/Treatment

Experimental: CAD analysis

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

Diagnostic Test: CAD analysis

CAD shows the radiologist automatically delineated areas of potential COVID-19 affection, together with an overall lung affection percentage.

No Intervention: No CAD analysis

No CAD analysis is shown to radiologist.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

RT-PCR confirmed patients of COVID-19

Exclusion Criteria:

15 or lower

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pius Brinzeu Timisoara County Emergency Hospital	Timisoara	Timis	Romania

Sponsors and Collaborators

Bogdan Bercean
Pius Brinzeu Timisoara County Emergency Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bogdan Bercean, Head of Artificial Intelligence, XVision

ClinicalTrials.gov Identifier:

NCT05282056

Other Study ID Numbers:

282/01.02.2022

First Posted:

Mar 16, 2022

Last Update Posted:

May 4, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bogdan Bercean, Head of Artificial Intelligence, XVision

CAD

Artificial Intelligence

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of May 4, 2022