- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06815848
Venous Drainage of the Craniocervical Junction: a Retrospective Anatomical Study (SVCR MR1) (SVCR MR1)
February 4, 2025 updated by: University Hospital, Brest
Venous Drainage of the Craniocervical Junction: a Retrospective Anatomical Study
This study aims to examine the feasibility of distinctly visualizing the different cervical venous networks (subcutaneous, muscular, extra-canalicular, and intra-canalicular) using dedicated magnetic resonance imaging (MRI) sequences.
Theoretically, these venous networks contribute to the complex distribution of blood drainage in the cervical region, but their precise identification on imaging remains challenging.The objectives of this research are twofold: first, to assess the ability of MRI to differentiate each venous network, thereby enhancing the anatomical and functional understanding of this region; and second, to explore the possibility of grouping patients according to the predominant venous network, which could reveal significant physiological variations and specific anatomical profiles.The results could not only refine the diagnosis of cervical vascular pathologies but also guide targeted therapeutic approaches.
Study Overview
Status
Active, not recruiting
Study Type
Observational
Enrollment (Actual)
160
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
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Brest, France, 29609
- CHU Brest
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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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients from the Brest University Hospital who underwent a cranio-cervical MRI with injected T1 GRE sequence between January 1, 2019, and November 1, 2024.
Description
Inclusion Criteria:
- Patient affiliated with a social security system
- Age >18 years
- Patient who underwent a T1 Angio-MRI with gradient echo and contrast agent of the cranio-cervical region, regardless of the indication, at the Brest University Hospital between 01/01/2019 and 01/11/2024
Exclusion Criteria:
- Patients under judicial protection (guardianship, curatorship, etc.) Refusal to participate (expressed opposition) History of venous occlusive pathology OR vascular pathology such as cerebral or spinal AVM/FAV History of posterior cranial fossa surgery OR surgical approach to the posterior cervical spine History of radiotherapy/chemotherapy/any known vein-toxic therapies
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of venous vessel in the four venous networks (subcutaneous, muscular, extra-canal, and intra-canal).
Time Frame: at the time of inclusion
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Determine, for each patient, which cervical venous network is dominant and identify whether each patient exhibits all four venous networks (subcutaneous, muscular, extra-canal, and intra-canal).
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at the time of inclusion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of vessel in each groups
Time Frame: at the time of inclusion
|
Assess the relative significance of each identified venous network.
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at the time of inclusion
|
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number of vessel on the left and the right in one patient
Time Frame: at the time of inclusion
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Examine whether there is a dominance of venous drainage on the right or left side in the same patient
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at the time of inclusion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
December 1, 2024
Primary Completion (Estimated)
May 31, 2025
Study Completion (Estimated)
May 31, 2025
Study Registration Dates
First Submitted
February 4, 2025
First Submitted That Met QC Criteria
February 4, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 4, 2025
Last Verified
December 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 29BRC24.0312 - SVCR MR1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
Data will be available beginning three years and ending fifteen years following the final study report completion
IPD Sharing Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH.
Requestors will be required to sign and complete a data access agreement
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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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