Back to resultsCOVID-19 Volumetric Quantification on Computer Tomography Using Computer Aided Diagnostics
Primary Purpose
COVID-19
Status
Completed
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
CAD analysis
Sponsored by
About this trial
This is an interventional diagnostic trial for COVID-19 focused on measuring CAD, AI, Artificial Intelligence
Eligibility Criteria
Inclusion Criteria:
- RT-PCR confirmed patients of COVID-19
Exclusion Criteria:
- 15 or lower
Sites / Locations
- Pius Brinzeu Timisoara County Emergency Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CAD analysis
No CAD analysis
Arm Description
The XVision COVID-19 computer aided diagnostic software is used by radiologist at CT analysis time
No CAD analysis is shown to radiologist.
Outcomes
Primary Outcome Measures
Mean difference of lung affection quantification percentage
The objective measurement of lung affection percentage is measured against pixel level labels. A lower difference mean better outcome.
Secondary Outcome Measures
Full Information
NCT ID
NCT05282056
First Posted
March 14, 2022
Last Updated
May 3, 2022
Sponsor
Bogdan Bercean
Collaborators
Pius Brinzeu Timisoara County Emergency Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05282056
Brief Title
COVID-19 Volumetric Quantification on Computer Tomography Using Computer Aided Diagnostics
Official Title
COVID-19 Volumetric Quantification on Computer Tomography Using Computer Aided Diagnostics
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 24, 2022 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
March 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bogdan Bercean
Collaborators
Pius Brinzeu Timisoara County Emergency Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
CAD, AI, Artificial Intelligence
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
CAD outputs are turned off for randomly chosen 50% of patients, which represent the control group. The other 50% are analysed using CAD
Masking
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.
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CAD analysis
Arm Type
Experimental
Arm Description
The XVision COVID-19 computer aided diagnostic software is used by radiologist at CT analysis time
Arm Title
No CAD analysis
Arm Type
No Intervention
Arm Description
No CAD analysis is shown to radiologist.
Intervention Type
Diagnostic Test
Intervention Name(s)
CAD analysis
Intervention Description
CAD shows the radiologist automatically delineated areas of potential COVID-19 affection, together with an overall lung affection percentage.
Primary Outcome Measure Information:
Title
Mean difference of lung affection quantification percentage
Description
The objective measurement of lung affection percentage is measured against pixel level labels. A lower difference mean better outcome.
Time Frame
At CT acquisition time, up to 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
RT-PCR confirmed patients of COVID-19
Exclusion Criteria:
15 or lower
Facility Information:
Facility Name
Pius Brinzeu Timisoara County Emergency Hospital
City
Timisoara
State/Province
Timis
Country
Romania
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
The statistical analysis, data points and possibly deidentified images.
Learn more about this trial
COVID-19 Volumetric Quantification on Computer Tomography Using Computer Aided Diagnostics
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