Predicting the growth of unruptured cerebral aneurysms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to recruit a large cohort of patients with unruptured intracranial aneurysms (UIA) to explore the relationship between arterial wall enhancement (AWE) observed in MR imaging and the risk of aneurysm growth. The study will involve comprehensive clinical phenotyping and imaging over a three-year follow-up period, assessing changes in aneurysm size and wall characteristics. By analyzing clinical, genetic, biological, and imaging data, the study seeks to develop predictive tools for the evolution of UIAs, potentially improving patient management strategies.

Why it matters

Who can join: the full rules

Inclusion Criteria :

* Subject carrying unruptured, asymptomatic and untreated typical IA of bifurcation, measured on conventional imaging (MRI, CTA or DSA) between 3 and 7 mm of larger diameter.
* Ability to be followed-up during 3 years decided in consensus multidisciplinary gathering.
* Age \> 18 years old.

Exclusion Criteria :

* A failure to obtain informed consent
* Contraindications for undergoing an MRI scan include : (heart pacemaker, a metallic foreign body (metal sliver) in their eye, or aneurysm clip in their brain, severe claustrophobia)
* Contraindications for a gadolinium contrast medium injection (:eGFR below 30 mL/min/1.73 m2, Previous or pre-existing nephrogenic systemic fibrosis, Previous anaphylactic/anaphylactoid reaction to gadolinium containing contrast agent, Acutely deteriorating renal function, Pregnancy and breast-feeding)
* A mycotic, fusiform-shaped, or dissecting IA, an IA in relation with an arteriovenous malformation
* A family history of polycystic kidney disease, Ehlers-Danlos syndrome, Marfan's syndrom, fibromuscular dysplasia, or Moya Moya disease
* Intra-cavernous UIA because the sinus cavernous that is fulfilled with venous blood precluded a reliable assessment of aneurysmal wall enhancement (AWE)

Where it's running

• Clairval's Hospital
  Marseille, Bouches-du-Rhône, France Recruiting
• Brest University Hospital
  Brest, Finistère, France Recruiting
• Bordeaux University Hospital
  Bordeaux, Gironde, France Recruiting
• Toulouse University Hospital
  Toulouse, Haute-Garonne, France Recruiting
• Limoges University Hospital
  Limoges, Haute-Vienne, France Recruiting
• Rennes University Hospital
  Rennes, Ille-et-Vilaine, France Recruiting

Study contacts

• Principal investigator: Romain BOURCIER, MD — Nantes University Hospital
• Study coordinator: Romain BOURCIER, MD
• Email: romain.bourcier@chu-nantes.fr
• Phone: 33240165608

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.