Venous Drainage of the Craniocervical Junction: a Retrosp... | NCT06815848

Studies
Venous Drainage of the Craniocervical Junction: a Retrospective Anatomical Study (SVCR MR1)

NCT06815848

Sponsor

University Hospital, Brest

Status

Active, not recruiting

Last Update Posted

Feb 10, 2025Actual

Enrollment

160Actual

Phase

Not provided

Conditions

Study of Venous Drainage of the Cranio-Cervical Junction Using MRI

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2024Actual

Primary Completion Date

May 31, 2025Estimated

Completion Date

May 31, 2025Estimated

First Submitted Date

Feb 4, 2025

First Submission Date that Met QC Criteria

Feb 4, 2025

First Posted Date

Feb 10, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2025

Last Update Posted Date

Feb 10, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

160Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of venous vessel in the four venous networks (subcutaneous, muscular, extra-canal, and intra-canal).	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).	at the time of inclusion

Secondary Outcomes

Measure	Description	Time Frame
Number of vessel in each groups	Assess the relative significance of each identified venous network.	at the time of inclusion
number of vessel on the left and the right in one patient	Examine whether there is a dominance of venous drainage on the right or left side in the same patient

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Chu Brest		Brest		29609	France

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All collected data that underlie results in a publication

Types

Study Protocol

Time Frame

Data will be available beginning three years and ending fifteen years following the final study report completion

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

URL

Not provided