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

May 3, 2022 updated by: Bogdan Bercean
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
    • Timis
      • Timisoara, Timis, Romania
        • Pius Brinzeu Timisoara County Emergency Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • RT-PCR confirmed patients of COVID-19

Exclusion Criteria:

  • 15 or lower

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean difference of lung affection quantification percentage
Time Frame: 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.
At CT acquisition time, up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bogdan Bercean

Collaborators

Pius Brinzeu Timisoara County Emergency Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2022

Primary Completion (Actual)

March 15, 2022

Study Completion (Actual)

March 15, 2022

Study Registration Dates

First Submitted

March 14, 2022

First Submitted That Met QC Criteria

March 14, 2022

First Posted (Actual)

March 16, 2022

Study Record Updates

Last Update Posted (Actual)

May 4, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 282/01.02.2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The statistical analysis, data points and possibly deidentified images.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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