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

NCT ID: NCT05282056

Last Updated: 2022-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-24

Study Completion Date

2022-03-15

Brief Summary

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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

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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.

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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CAD analysis

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

Group Type EXPERIMENTAL

CAD analysis

Intervention Type DIAGNOSTIC_TEST

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

No CAD analysis

No CAD analysis is shown to radiologist.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CAD analysis

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* RT-PCR confirmed patients of COVID-19

Exclusion Criteria

* 15 or lower
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pius Brinzeu Timisoara County Emergency Hospital

UNKNOWN

Sponsor Role collaborator

Bogdan Bercean

INDUSTRY

Sponsor Role lead

Responsible Party

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Bogdan Bercean

Head of Artificial Intelligence

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Pius Brinzeu Timisoara County Emergency Hospital

Timișoara, Timiș County, Romania

Site Status

Countries

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Romania

References

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Bercean BA, Birhala A, Ardelean PG, Barbulescu I, Benta MM, Rasadean CD, Costachescu D, Avramescu C, Tenescu A, Iarca S, Buburuzan AS, Marcu M, Birsasteanu F. Evidence of a cognitive bias in the quantification of COVID-19 with CT: an artificial intelligence randomised clinical trial. Sci Rep. 2023 Mar 25;13(1):4887. doi: 10.1038/s41598-023-31910-3.

Reference Type DERIVED
PMID: 36966179 (View on PubMed)

Other Identifiers

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282/01.02.2022

Identifier Type: -

Identifier Source: org_study_id

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