COVID-19NCT05282056
COVID-19 Volumetric Quantification on Computer Tomography Using Computer Aided Diagnostics
A study testing CAD analysis in people with COVID-19, run by Bogdan Bercean at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- CAD analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteRomania
- Study dates
- 24 Feb 2022to 15 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- RT-PCR confirmed patients of COVID-19
Who cannot join
- 15 or lower
Trial locations and contacts
1 site in 1 country.
Romania1 site
Pius Brinzeu Timisoara County Emergency Hospital
Timișoara, Timiș County
About this study
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- CAD analysis
- Keywords
- CAD, AI, Artificial Intelligence
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD analysisDiagnostic test
CAD shows the radiologist automatically delineated areas of potential COVID-19 affection, together with an overall lung affection percentage.
| Study group | Role | What they receive |
|---|---|---|
| CAD analysis | Experimental | The XVision COVID-19 computer aided diagnostic software is used by radiologist at CT analysis time Receives: Diagnostic Test: CAD analysis |
| No CAD analysis | No intervention | No CAD analysis is shown to radiologist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At CT acquisition time, up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start24 Feb 2022
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bogdan Bercean
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pius Brinzeu Timisoara County Emergency Hospital
- Responsible party
- Sponsor-investigator, Bogdan Bercean, XVision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282056
- Sponsor's protocol ID
- 282/01.02.2022
- Status last verified
- May 2022
- First submitted
- 14 Mar 2022
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The statistical analysis, data points and possibly deidentified images.
Publications
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.
PubMed 36966179
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Volumetric Quantification on Computer Tomography Using Computer Aided Diagnostics
- ClinicalTrials.gov ID
- NCT05282056
- Acronym / sponsor ID
- 282/01.02.2022
- Conditions
- COVID-19
- Keywords
- CAD, AI, Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Bogdan BerceanIndustry (pharma, biotech, devices)
- Collaborators
- Pius Brinzeu Timisoara County Emergency Hospital
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| CAD analysis | Experimental | Diagnostic Test: CAD analysisThe XVision COVID-19 computer aided diagnostic software is used by radiologist at CT analysis time |
| No CAD analysis | No intervention | –No CAD analysis is shown to radiologist. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- RT-PCR confirmed patients of COVID-19
Key exclusion criteria (1 listed)
- 15 or lower
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAD analysisCAD shows the radiologist automatically delineated areas of potential COVID-19 affection, together with an overall lung affection percentage. | Diagnostic test | CAD analysis |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Derived from this study: PubMed 36966179Bercean 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.
- Individual participant dataSharing planned: Undecided. The statistical analysis, data points and possibly deidentified images.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAD analysis in people with COVID-19, run by Bogdan Bercean at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference of lung affection quantification percentage (time frame: At CT acquisition time, up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05282056, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.