Predicting the growth of unruptured cerebral aneurysms
Unruptured Cerebral Aneurysm: Prediction of Evolution
Nantes University Hospital · NCT04578808
This study is trying to see if certain imaging results can help predict how unruptured brain aneurysms grow over time in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital (other) |
| Locations | 21 sites (Marseille, Bouches-du-Rhône and 20 other locations) |
| Trial ID | NCT04578808 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with unruptured, asymptomatic intracranial aneurysms measuring between 3 and 7 mm.
Not a fit: Patients with contraindications for MRI or gadolinium contrast, or those with specific types of aneurysms or severe claustrophobia, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the risk factors for aneurysm growth, leading to better monitoring and treatment decisions for patients with unruptured cerebral aneurysms.
How similar studies have performed: Previous studies have suggested the potential of imaging techniques like AWE in predicting aneurysm growth, but this approach is being explored in a novel, multicentric prospective cohort setting.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Marseille, Bouches-du-Rhône and 20 other locations
- 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)
- Tours University Hospital — Tours, Indre-et-Loire, France (RECRUITING)
- Nantes University Hospital — Nantes, Loire-Atlantique, France (RECRUITING)
- Angers University Hospital — Angers, Maine et Loire, France (RECRUITING)
- Reims University Hospital — Reims, Marne, France (NOT_YET_RECRUITING)
- Nancy University Hospital — Nancy, Meurthe-et-Moselle, France (RECRUITING)
- AP-HP La Pitié-Salpêtrière Hospital — Paris, Paris, France (RECRUITING)
- AP-HP Le Kremlin Bicêtre Hospital — Paris, Paris, France (RECRUITING)
- Rostchild Foundation Hospital — Paris, Paris, France (RECRUITING)
- Rouen University Hospital — Rouen, Seine-Maritime, France (RECRUITING)
- Amiens University Hospital — Amiens, Somme, France (RECRUITING)
- Creteil University Hospital — Créteil, Val-de-Marne, France (NOT_YET_RECRUITING)
- St Anne HIA — Toulon, France (RECRUITING)
- Ste Anne's Hospital — Paris, Île-de-France Region, France (RECRUITING)
- UMC Utrecht — Utrecht, Netherlands (RECRUITING)
- InselHospital Bern — Bern, Switzerland (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Romain BOURCIER, MD — Nantes University Hospital
- Study coordinator: Romain BOURCIER, MD
- Email: romain.bourcier@chu-nantes.fr
- Phone: 33240165608
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Unruptured Intracranial Aneurysm, Unruptured Cerebral Aneurysm, Aneurysm Prediction Growth, Unruptured Intracranial aneurysm