- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04578808
Unruptured Cerebral Aneurysm: Prediction of Evolution (U-CAN)
March 18, 2024 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
- Name: Romain BOURCIER, MD
- Phone Number: 33240165608
- Email: romain.bourcier@chu-nantes.fr
Study Locations
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Paris, France, 75000
- Not yet recruiting
- AP-HP La Pitié-Salpêtrière Hospital
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Paris, France, 75000
- Not yet recruiting
- AP-HP Le Kremlin Bicêtre Hospital
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Paris, France, 75000
- Not yet recruiting
- Rostchild Foundation Hospital
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Bouches-du-Rhône
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Marseille, Bouches-du-Rhône, France, 13000
- Not yet recruiting
- Clairval's Hospital
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Finistère
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Brest, Finistère, France, 29200
- Not yet recruiting
- Brest University Hospital
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Gironde
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Bordeaux, Gironde, France, 33000
- Not yet recruiting
- Bordeaux University Hospital
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Haute-Garonne
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Toulouse, Haute-Garonne, France, 31000
- Not yet recruiting
- Toulouse University Hospital
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Haute-Vienne
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Limoges, Haute-Vienne, France, 87000
- Not yet recruiting
- Limoges University Hospital
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Ile De France
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Paris, Ile De France, France, 75674
- Not yet recruiting
- Ste Anne's Hospital
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Ille-et-Vilaine
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Rennes, Ille-et-Vilaine, France, 35000
- Not yet recruiting
- Rennes University Hospital
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Indre-et-Loire
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Tours, Indre-et-Loire, France, 37000
- Not yet recruiting
- Tours University Hospital
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Loire-Atlantique
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Nantes, Loire-Atlantique, France, 44000
- Recruiting
- Nantes University Hospital
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Principal Investigator:
- Romain BOURCIER, MD
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Maine Et Loire
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Angers, Maine Et Loire, France, 49000
- Not yet recruiting
- Angers University Hospital
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Marne
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Reims, Marne, France, 51100
- Not yet recruiting
- Reims University Hospital
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Meurthe-et-Moselle
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Nancy, Meurthe-et-Moselle, France, 54000
- Not yet recruiting
- Nancy University Hospital
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Seine-Maritime
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Rouen, Seine-Maritime, France, 76000
- Not yet recruiting
- Rouen University Hospital
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Somme
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Amiens, Somme, France, 80000
- Not yet recruiting
- Amiens university hospital
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Val-de-Marne
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Créteil, Val-de-Marne, France, 94000
- Not yet recruiting
- Creteil University Hospital
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Utrecht, Netherlands, 3500
- Not yet recruiting
- UMC Utrecht
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Bern, Switzerland, 3000
- Not yet recruiting
- InselHospital Bern
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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.
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5 years
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Predictive value of UIA wall enhancement for UIA growth
Time Frame: at 1 year
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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
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Evaluation of the quality of life (QOL) of untreated patients with UIA during the follow-up.
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5 years
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AWE variation patterns related to the growth of UIA.
Time Frame: 5 years
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Detection of other AWE variation patterns related to growth during the follow-up in order to improve the follow-up of UIA patients
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5 years
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Clinical, genetics or biological factors related to the growth of UIA.
Time Frame: 5 years
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Clinical, genetic (blood serum level of circulating ANGPTL6) and biological (plasma factors as circulating ANGPTL6 levels, metalloproteinase…) features recorded.
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5 years
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Incidence of growth of UIA.
Time Frame: 5 years
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Incidence of growth, stratified by clinical, genetics or biological features.
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5 years
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Incidence of IA rupture
Time Frame: 5 years
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Incidence of IA rupture, stratified by clinical, genetics or biological features.
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5 years
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quality of life patients related to the growth of UIA.
Time Frame: 5 years
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Completion of standardized EQ5D questionnaire to measure quality of life patients
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5 years
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Construction of an automatized tool of AWE pattern
Time Frame: 5 years
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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.
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5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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, 2029
Study Completion (Estimated)
March 15, 2029
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)
March 19, 2024
Last Update Submitted That Met QC Criteria
March 18, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
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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