Unruptured Intracranial AneurysmU-CANNCT04578808
Unruptured Cerebral Aneurysm: Prediction of Evolution
An observational study of Unruptured Intracranial Aneurysm, run by Nantes University Hospital at 29 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unruptured Intracranial Aneurysm
- What is being tested?
- Unruptured intracranial aneurysms
- How many people
- 1,000 participants
- Where
- 29 sitesin 3 countries
- Study dates
- 19 Aug 2019to 15 Mar 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
29 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
29 sites in 3 countries
France27 sites, 26 recruiting
- Recruiting
Amiens University Hospital
Amiens, Somme, 80000
- Recruiting
Angers University Hospital
Angers, Maine et Loire, 49000
- Recruiting
CHU de Besançon
Besançon
Alessandra BIONDI, +33 3 81 66 81 66, biondi.alessandra@gmail.com
Alessandra BIONDI
- Recruiting
Bordeaux University Hospital
Bordeaux, Gironde, 33000
- Recruiting
Brest University Hospital
Brest, Finistère, 29200
- Recruiting
CHU de Caen
Caen
Charlotte BARBIER, +33 2 31 06 31 06, barbier-ch@chu-caen.fr
Charlotte BARBIER
- Recruiting
CHU de Clermont Ferrand
Clermont-Ferrand
Emmanuel CHABERT, +33 4 73 751 747, echabert@chu-clermontferrand.fr
Emmanuel CHABERT
- Not yet recruiting
Hôpitaux Civils de Colmar
Colmar
Pablo Ariel LEBEDINSKY, MD, +33 3.89.12.44.39, pablo.lebedinsky@ch-colmar.fr
Pablo Ariel LEBEDINSKY
- Recruiting
CHU Dijon
Dijon
Pierre THOUANT, +33 3 80 29 30 31, pierrethouant@gmail.com
Pierre THOUANT
- Recruiting
Limoges University Hospital
Limoges, Haute-Vienne, 87000
- Recruiting
Clairval's Hospital
Marseille, Bouches-du-Rhône, 13000
- Recruiting
Nancy University Hospital
Nancy, Meurthe-et-Moselle, 54000
- Recruiting
Nantes University Hospital
Nantes, Loire-Atlantique, 44000
Romain BOURCIER, MD
- Recruiting
AP-HP La Pitié-Salpêtrière Hospital
Paris, Paris, 75000
- Recruiting
AP-HP Le Kremlin Bicêtre Hospital
Paris, Paris, 75000
- Recruiting
Rostchild Foundation Hospital
Paris, Paris, 75000
- Recruiting
Ste Anne's Hospital
Paris, Île-de-France Region, 75674
- Recruiting
CHU de Poitiers
Poitiers
Samy BOUCEBCI, +33 5 49 44 44 44, Samy.BOUCEBCI@chu-poitiers.fr
Samy BOUCEBCI
- Withdrawn
Reims University Hospital
Reims, Marne, 51100
- Recruiting
Rennes University Hospital
Rennes, Ille-et-Vilaine, 35000
- Recruiting
Rouen University Hospital
Rouen, Seine-Maritime, 76000
- Recruiting
CHU de saint Etienne
Saint-Etienne
Marina SACHET, +33 4 77 82 80 00, Marina.Sachet@chu-st-etienne.fr
Marina SACHET
- Recruiting
CHU de Strasbourg
Strasbourg
Raoul POP, +33 3 88 11 67 68, raoul.pop@chru-strasbourg.fr
Raoul POP
- Recruiting
Hôpital Foch
Suresnes
Arturo CONSOLI, +33 1 46 25 20 00, a.consoli@hopital-foch.com
Arturo CONSOLI
- Recruiting
St Anne HIA
Toulon
Quentin Holay, qholay@gmail.com
- Recruiting
Toulouse University Hospital
Toulouse, Haute-Garonne, 31000
- Recruiting
Tours University Hospital
Tours, Indre-et-Loire, 37000
Switzerland1 site, 1 recruiting
- Not yet recruiting
InselHospital Bern
Bern, 3000
About this study
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.
Read the 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).
- Conditions
- Unruptured Intracranial Aneurysm
- Being tested
- Unruptured intracranial aneurysms
- Keywords
- Unruptured Cerebral Aneurysm, Aneurysm Prediction Growth, Unruptured Intracranial aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unruptured intracranial aneurysmsOther
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
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.
Measured: at 1 year
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.
Measured: at 3 years
Secondary outcomes (7)
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.
Measured: 5 years
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
Measured: 5 years
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.
Measured: 5 years
Incidence of growth of UIA.
Incidence of growth, stratified by clinical, genetics or biological features.
Measured: 5 years
Incidence of IA rupture
Incidence of IA rupture, stratified by clinical, genetics or biological features.
Measured: 5 years
quality of life patients related to the growth of UIA.
Completion of standardized EQ5D questionnaire to measure quality of life patients
Measured: 5 years
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start19 Aug 2019
- Primary completion15 Mar 2031 (estimated)
- Study completion15 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unruptured Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier St Anne
- Responsible party
- Sponsor
- Investigators
- Romain BOURCIER, MD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578808
- Sponsor's protocol ID
- RC20_0012
- Acronym
- U-CAN
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2020
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unruptured Cerebral Aneurysm: Prediction of Evolution
- ClinicalTrials.gov ID
- NCT04578808
- Acronym / sponsor ID
- U-CAN / RC20_0012
- Conditions
- Unruptured Intracranial Aneurysm
- Keywords
- Unruptured Cerebral Aneurysm, Aneurysm Prediction Growth, Unruptured Intracranial aneurysm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Centre Hospitalier St Anne
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 15 Mar 2031 (estimated)
- Study completion
- 15 Mar 2031 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unruptured intracranial aneurysmsUIA 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). | Other | – |
Primary outcome
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.
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.
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.
7 secondary outcomes
Quality of life related to the growth of UIA.
Time frame: 5 years
AWE variation patterns related to the growth of UIA.
Time frame: 5 years
Clinical, genetics or biological factors related to the growth of UIA.
Time frame: 5 years
Incidence of growth of UIA.
Time frame: 5 years
Incidence of IA rupture
Time frame: 5 years
quality of life patients related to the growth of UIA.
Time frame: 5 years
Construction of an automatized tool of AWE pattern
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Romain BOURCIER, MD principal investigator
Nantes University Hospital
29 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unruptured Intracranial Aneurysm, run by Nantes University Hospital at 29 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in France, Netherlands, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Romain BOURCIER, MD (33240165608, romain.bourcier@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.