MRI Analysis in the Growth of Cerebral Aneurysms

NCT06705452 | Not Yet Recruiting

• 1 other identifier: PO24101
• Study Type: interventional
• Target: 281
• Locations: 1 country
• Sites: 1

Brief Summary

An intracranial aneurysm is defined as a localized dilatation of the cerebral arteries, which can potentially lead to rupture and subsequent hemorrhagic stroke. The mechanisms by which aneurysms develop and grow remain unknown. The objective of this project is to utilize MRI, a routine non-invasive examination for detecting and following up aneurysms, to identify visually and quantitatively an aneurysm growth and relevant biomarkers that can predict the risk of aneurysm development.

Conditions

Unruptured Intracranial Aneurysm

Keywords

Aneurysm Growth; Unruptured Intracranial aneurysm; Cerebral Aneurysm; Vascular Diseases; Intracranial Arterial Diseases; Intracranial Aneurysm

Outcome Measures

Primary Outcomes (1)

• Evolution of the shape of the aneurysm

  Millimetric quantification of the three-dimensional evolution of the shape of the aneurysm sac, calculated using a computer algorithm

  At 3 years

Study Arms (1)

Patients with unruptured and untreated aneurysms

EXPERIMENTAL

Patients in radiology for the first diagnostic evaluation or the follow-up of unruptured and untreated aneurysms.

Other: Additional 4D Flow MRI or additional 4D Flow sequence

Interventions

Additional 4D Flow MRI or additional 4D Flow sequence OTHER

Additional 4D Flow MRI or additional 4D Flow sequence

Patients with unruptured and untreated aneurysms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with one or more unruptured intracranial aneurysms followed up at the participating center. Patients may have other ruptured and/or treated aneurysms
• Patient older than 18 years
• Patient consenting to participate to the study
• Patient enrolled in the national healthcare insurance program

You may not qualify if:

• Patients who have already received surgical or endovascular treatment for all their aneurysm(s), or who are due to receive such treatment in less than 2 months.
• Patients with only ruptured aneurysm(s)
• Patients with arteriovenous malformations (treated or untreated)
• Patients with a contraindication to MRI
• Patients with an allergy to one of the contrast agents (Iodixanol, Gadoteric acid)
• Pregnant or breast-feeding patients
• Patients protected by law.

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, 51100, France

Location

MeSH Terms

Conditions

Intracranial Aneurysm; Vascular Diseases; Intracranial Arterial Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Cardiovascular Diseases

Central Study Contacts

Sébastien SOIZE

CONTACT

03 10 73 62 17; ssoize@chu-reims.fr

Christophe PORTEFAIX

CONTACT

03 26 78 94 82; cportefaix@chu-reims.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2032
• Last Updated: November 26, 2024

Record last verified: 2024-11

Locations

FR (1)