Bone Vascular TumorNCT05628792
In Vivo Depiction Of Bone Vascularization With UHR-CT CT And Deep Learning Algorithm Reconstruction: A Preliminary Study
An observational study of Bone Vascular Tumor, run by Central Hospital, Nancy, France.
Trial summary
To evaluate the image quality and ability to depict in vivo bone vascularization with an ultra-high-resolution computed tomography (UHR-CT) scanner using a deep learning reconstruction (DLR) and hybrid iterative reconstruction (HIR) algorithms, compared to simulated conventional CT, using osteoid osteoma (OO) as a… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bone Vascular Tumor
- What is being tested?
- CT
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2022to 31 Mar 2023
- Phase
- Observational
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: retrospective inclusion of all histologically proven Osteoid Osteoma referred to our department for CT imaging
Who may be able to join
- Proven osteoid osteoma
- Ultra High Resolution CT
Who cannot join
- None
Trial locations and contacts
No sites are listed yet.
About this study
To evaluate the image quality and ability to depict in vivo bone vascularization with an ultra-high-resolution computed tomography (UHR-CT) scanner using a deep learning reconstruction (DLR) and hybrid iterative reconstruction (HIR) algorithms, compared to simulated conventional CT, using osteoid osteoma (OO) as a model.
- Conditions
- Bone Vascular Tumor
- Being tested
- CT
- Keywords
- CT, Osteoid Osteoma, Ultra High Resolution CT
- Medical subject headings
- Osteoma, Osteoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTDiagnostic test
Ultra High Resolution CT scan
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cortical vessels
Number
Measured: Retrospective review of all ultra high resolution CT of the precedent 2 years
Number of nidus vessels
Number
Measured: Retrospective review of all ultra high resolution CT of the precedent 2 years
Secondary outcomes (1)
Confidence Score
1 (weak) to 5 (strong)
Measured: Retrospective review of all ultra high resolution CT of the precedent 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start20 Dec 2022 (estimated)
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Vascular TumorStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GILLET Romain, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628792
- Sponsor's protocol ID
- N°2-RCB/EUDRACT
- Status last verified
- Nov 2022
- First submitted
- 28 Oct 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Depiction Of Bone Vascularization With UHR-CT CT And Deep Learning Algorithm Reconstruction: A Preliminary Study
- ClinicalTrials.gov ID
- NCT05628792
- Acronym / sponsor ID
- N°2-RCB/EUDRACT
- Conditions
- Bone Vascular Tumor
- Keywords
- CT, Osteoid Osteoma, Ultra High Resolution CT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 20 Dec 2022 (estimated)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 29 Nov 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.
To evaluate the image quality and ability to depict in vivo bone vascularization with an ultra-high-resolution computed tomography (UHR-CT) scanner using a deep learning reconstruction (DLR) and hybrid iterative reconstruction (HIR) algorithms, compared to simulated conventional CT, using osteoid osteoma (OO) as a model.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- retrospective inclusion of all histologically proven Osteoid Osteoma referred to our department for CT imaging
Key inclusion criteria (2 listed)
- Proven osteoid osteoma
- Ultra High Resolution CT
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| CTUltra High Resolution CT scan | Diagnostic test | – |
Primary outcome
Number of cortical vessels
Time frame: Retrospective review of all ultra high resolution CT of the precedent 2 years
Number
Number of nidus vessels
Time frame: Retrospective review of all ultra high resolution CT of the precedent 2 years
Number
1 secondary outcome
Confidence Score
Time frame: Retrospective review of all ultra high resolution CT of the precedent 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Vascular Tumor, run by Central Hospital, Nancy, France.
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 2 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: status not confirmed, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Romain GILLET, MD (0680987216, romain_gillet3@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cortical vessels (time frame: Retrospective review of all ultra high resolution CT of the precedent 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2022.