Unruptured Cerebral Aneurysm: Prediction of Evolution

Unruptured Intracranial Aneurysm Clinical Trial

— U-CAN  

Official title:

Unruptured Cerebral Aneurysm: Prediction of Evolution

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04578808
• Other study ID #: RC20_0012
• Status: Recruiting
• Start date: August 19, 2019
• Est. completion date: March 15, 2029

Study information

• Verified date: March 2024
• Source: Nantes University Hospital
• Contact: Romain BOURCIER, MD
• Phone: 33240165608
• Email: romain.bourcier[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The protocol has many assets. A prospective nationwide recruitment allows for the inclusion of a large cohort of patients with UIA. It will combine accurate clinical phenotyping and comprehensive imaging with CAWE screening. Besides, it will enable to exploit metadata and to explore new pathophysiological pathways of interest by crossing clinical, genetic, biological, and imaging information.

Description:

Management of small (<7mm) unruptured intracranial aneurysms (UIA) remains controversial. Previous retrospective studies have suggested that post gadolinium arterial wall enhancement (AWE) of unruptured intracranial aneurysms on MR imaging may reflect aneurysm wall instability, and hence may highlight a higher risk of UIA growth over time. This multicentric prospective cohort aims at exploring vessel wall imaging findings of UIAs with consecutive follow-up to substantiate these assumptions.The objective is to develop diagnostic and predictive tools for the risk of IA evolution. The aim is to demonstrate in clinical practice the predictive value of (AWE) for UIA growth. The growth will be determined by any modification of the UIA measurement. Both UIA growth and the UIA wall enhancement will be assessed in consensus by two expert neuroradiologists.The French prospective UCAN project is a non-interventional international wide and multicentric prospective cohort. UIA of bifurcation between 3 and 7 mm for whom a clinical and imaging follow-up without occlusion treatment was scheduled by local multidisciplinary staff will be included. Extensive clinical, biological and imaging data will be recorded during a 3 years follow-up (visits at 1 and 3 years after inclusion).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 15, 2029
• Est. primary completion date: March 15, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Unruptured Intracranial Aneurysm

Intervention

Other:
• Unruptured intracranial aneurysms
UIA of bifurcation between 3 and 7 mm for whom a clinical and imaging follow-up without occlusion treatment was scheduled by local multidisciplinary staff will be included. Extensive clinical, biological and imaging data will be recorded during a 3 years follow-up (visits at 1 and 3 years after inclusion).

Locations

Country	Name	City	State
France	Amiens University Hospital	Amiens	Somme
France	Angers University Hospital	Angers	Maine Et Loire
France	Bordeaux University Hospital	Bordeaux	Gironde
France	Brest University Hospital	Brest	Finistère
France	Creteil University Hospital	Créteil	Val-de-Marne
France	Limoges University Hospital	Limoges	Haute-Vienne
France	Clairval's Hospital	Marseille	Bouches-du-Rhône
France	Nancy University Hospital	Nancy	Meurthe-et-Moselle
France	Nantes University Hospital	Nantes	Loire-Atlantique
France	AP-HP La Pitié-Salpêtrière Hospital	Paris
France	AP-HP Le Kremlin Bicêtre Hospital	Paris
France	Rostchild Foundation Hospital	Paris
France	Ste Anne's Hospital	Paris	Ile De France
France	Reims University Hospital	Reims	Marne
France	Rennes University Hospital	Rennes	Ille-et-Vilaine
France	Rouen University Hospital	Rouen	Seine-Maritime
France	Toulouse University Hospital	Toulouse	Haute-Garonne
France	Tours University Hospital	Tours	Indre-et-Loire
Netherlands	UMC Utrecht	Utrecht
Switzerland	InselHospital Bern	Bern

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	Centre Hospitalier St Anne

Countries where clinical trial is conducted

France,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The aim is to evaluate in clinical practice the predictive value of UIA wall enhancement for UIA growth. It will allow to set up a secure, efficient and personalized follow-up.	In order to evaluate the informative value of AWE for UIA growth, investigators will consider as primary endpoint the growth of the UIA after the complete follow-up at 3 years.	5 years
Primary	Predictive value of UIA wall enhancement for UIA growth	This event could occur at any time during the follow-up if an UIA becomes symptomatic but will be systematically assessed by MRI. UIA growth will be assessed blindly and independently by two expert neuroradiologists, routinely involved in UIA management and disagreement will be solved by consensus with involvement of a third expert. UIA wall enhancement status will be defined independently by two different expert neuroradiologists, with > 5yrs experience in intracranial vessel wall imaging. Disagreement will be solved by consensus with involvement of a third expert.	at 1 year
Primary	Predictive value of UIA wall enhancement for UIA growth	This event could occur at any time during the follow-up if an UIA becomes symptomatic but will be systematically assessed by MRI. UIA growth will be assessed blindly and independently by two expert neuroradiologists, routinely involved in UIA management and disagreement will be solved by consensus with involvement of a third expert. UIA wall enhancement status will be defined independently by two different expert neuroradiologists, with > 5yrs experience in intracranial vessel wall imaging. Disagreement will be solved by consensus with involvement of a third expert.	at 3 years
Secondary	Quality of life related to the growth of UIA.	Evaluation of the quality of life (QOL) of untreated patients with UIA during the follow-up.	5 years
Secondary	AWE variation patterns related to the growth of UIA.	Detection of other AWE variation patterns related to growth during the follow-up in order to improve the follow-up of UIA patients	5 years
Secondary	Clinical, genetics or biological factors related to the growth of UIA.	Clinical, genetic (blood serum level of circulating ANGPTL6) and biological (plasma factors as circulating ANGPTL6 levels, metalloproteinase…) features recorded.	5 years
Secondary	Incidence of growth of UIA.	Incidence of growth, stratified by clinical, genetics or biological features.	5 years
Secondary	Incidence of IA rupture	Incidence of IA rupture, stratified by clinical, genetics or biological features.	5 years
Secondary	quality of life patients related to the growth of UIA.	Completion of standardized EQ5D questionnaire to measure quality of life patients	5 years
Secondary	Construction of an automatized tool of AWE pattern	Construction and evaluation of an automatized tool of AWE patterns, as compared to the visual analysis of experts, in the form of a decision-making tool.	5 years