Unruptured Cerebral Aneurysm: Prediction of Evolution (U-CAN)

April 10, 2026 updated by: Nantes University Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Toulon, France
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13000
        • Recruiting
        • Clairval's Hospital
    • Finistère
      • Brest, Finistère, France, 29200
        • Recruiting
        • Brest University Hospital
    • Gironde
      • Bordeaux, Gironde, France, 33000
        • Recruiting
        • Bordeaux University Hospital
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31000
        • Recruiting
        • Toulouse University Hospital
    • Haute-Vienne
      • Limoges, Haute-Vienne, France, 87000
        • Recruiting
        • Limoges University Hospital
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France, 35000
        • Recruiting
        • Rennes University Hospital
    • Indre-et-Loire
      • Tours, Indre-et-Loire, France, 37000
        • Recruiting
        • Tours University Hospital
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44000
        • Recruiting
        • Nantes University Hospital
        • Principal Investigator:
          • Romain BOURCIER, MD
    • Maine et Loire
      • Angers, Maine et Loire, France, 49000
        • Recruiting
        • Angers University Hospital
    • Marne
      • Reims, Marne, France, 51100
        • Not yet recruiting
        • Reims University Hospital
    • Meurthe-et-Moselle
      • Nancy, Meurthe-et-Moselle, France, 54000
        • Recruiting
        • Nancy University Hospital
    • Paris
      • Paris, Paris, France, 75000
        • Recruiting
        • AP-HP La Pitié-Salpêtrière Hospital
      • Paris, Paris, France, 75000
        • Recruiting
        • AP-HP Le Kremlin Bicêtre Hospital
      • Paris, Paris, France, 75000
        • Recruiting
        • Rostchild Foundation Hospital
    • Seine-Maritime
      • Rouen, Seine-Maritime, France, 76000
        • Recruiting
        • Rouen University Hospital
    • Somme
      • Amiens, Somme, France, 80000
        • Recruiting
        • Amiens University Hospital
    • Val-de-Marne
      • Créteil, Val-de-Marne, France, 94000
        • Not yet recruiting
        • Creteil University Hospital
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75674
        • Recruiting
        • Ste Anne's Hospital
  • Netherlands
      • Utrecht, Netherlands, 3500
        • Recruiting
        • UMC Utrecht
  • Switzerland
      • Bern, Switzerland, 3000
        • Not yet recruiting
        • InselHospital Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The recruited population is composed of subjects carrying unruptured asymptomatic typical IA of bifurcation for whom a clinical, a biological and an imaging follow-up, without occlusion treatment, was scheduled by local multidisciplinary staff.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 5 years
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
Predictive value of UIA wall enhancement for UIA growth
Time Frame: at 1 year
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
Predictive value of UIA wall enhancement for UIA growth
Time Frame: at 3 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life related to the growth of UIA.
Time Frame: 5 years
Evaluation of the quality of life (QOL) of untreated patients with UIA during the follow-up.
5 years
AWE variation patterns related to the growth of UIA.
Time Frame: 5 years
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
Clinical, genetics or biological factors related to the growth of UIA.
Time Frame: 5 years
Clinical, genetic (blood serum level of circulating ANGPTL6) and biological (plasma factors as circulating ANGPTL6 levels, metalloproteinase…) features recorded.
5 years
Incidence of growth of UIA.
Time Frame: 5 years
Incidence of growth, stratified by clinical, genetics or biological features.
5 years
Incidence of IA rupture
Time Frame: 5 years
Incidence of IA rupture, stratified by clinical, genetics or biological features.
5 years
quality of life patients related to the growth of UIA.
Time Frame: 5 years
Completion of standardized EQ5D questionnaire to measure quality of life patients
5 years
Construction of an automatized tool of AWE pattern
Time Frame: 5 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Collaborators

Centre Hospitalier St Anne

Investigators

  • Principal Investigator: Romain BOURCIER, MD, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2019

Primary Completion (Estimated)

March 15, 2031

Study Completion (Estimated)

March 15, 2031

Study Registration Dates

First Submitted

September 9, 2020

First Submitted That Met QC Criteria

October 1, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC20_0012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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