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

22 september 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Oavbrutet intrakraniellt aneurysm

Intervention / Behandling

Övrig: Unruptured intracranial aneurysms

Detaljerad beskrivning

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).

Studietyp

Observationell

Inskrivning (Beräknad)

1000

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Namn: Romain BOURCIER, MD
Telefonnummer: 33240165608
E-post: romain.bourcier@chu-nantes.fr

Studieorter

Frankrike
- - Besançon, Frankrike
    - Rekrytering
    - CHU de Besançon
    - Huvudutredare:
      
      Alessandra BIONDI
    - Kontakt:
      
      Alessandra BIONDI
      
      Telefonnummer: +33 3 81 66 81 66
      
      E-post: biondi.alessandra@gmail.com
  - Caen, Frankrike
    - Rekrytering
    - CHU de Caen
    - Kontakt:
      
      Charlotte BARBIER
      
      Telefonnummer: +33 2 31 06 31 06
      
      E-post: barbier-ch@chu-caen.fr
    - Huvudutredare:
      
      Charlotte BARBIER
  - Clermont-Ferrand, Frankrike
    - Rekrytering
    - CHU de Clermont Ferrand
    - Kontakt:
      
      Emmanuel CHABERT
      
      Telefonnummer: +33 4 73 751 747
      
      E-post: echabert@chu-clermontferrand.fr
    - Huvudutredare:
      
      Emmanuel CHABERT
  - Colmar, Frankrike
    - Har inte rekryterat ännu
    - Hôpitaux Civils de Colmar
    - Kontakt:
      
      Pablo Ariel LEBEDINSKY, MD
      
      Telefonnummer: +33 3.89.12.44.39
      
      E-post: pablo.lebedinsky@ch-colmar.fr
    - Huvudutredare:
      
      Pablo Ariel LEBEDINSKY
  - Dijon, Frankrike
    - Rekrytering
    - CHU Dijon
    - Kontakt:
      
      Pierre THOUANT
      
      Telefonnummer: +33 3 80 29 30 31
      
      E-post: pierrethouant@gmail.com
    - Huvudutredare:
      
      Pierre THOUANT
  - Poitiers, Frankrike
    - Rekrytering
    - CHU de Poitiers
    - Huvudutredare:
      
      Samy BOUCEBCI
    - Kontakt:
      
      Samy BOUCEBCI
      
      Telefonnummer: +33 5 49 44 44 44
      
      E-post: Samy.BOUCEBCI@chu-poitiers.fr
  - Saint-Etienne, Frankrike
    - Rekrytering
    - CHU de saint Etienne
    - Huvudutredare:
      
      Marina SACHET
    - Kontakt:
      
      Marina SACHET
      
      Telefonnummer: +33 4 77 82 80 00
      
      E-post: Marina.Sachet@chu-st-etienne.fr
  - Strasbourg, Frankrike
    - Rekrytering
    - CHU de Strasbourg
    - Huvudutredare:
      
      Raoul POP
    - Kontakt:
      
      Raoul POP
      
      Telefonnummer: +33 3 88 11 67 68
      
      E-post: raoul.pop@chru-strasbourg.fr
  - Suresnes, Frankrike
    - Rekrytering
    - Hôpital Foch
    - Huvudutredare:
      
      Arturo CONSOLI
    - Kontakt:
      
      Arturo CONSOLI
      
      Telefonnummer: +33 1 46 25 20 00
      
      E-post: a.consoli@hopital-foch.com
  - Toulon, Frankrike
    - Rekrytering
    - St Anne HIA
    - Kontakt:
      
      Quentin Holay
      
      E-post: qholay@gmail.com
- Bouches-du-Rhône
  - Marseille, Bouches-du-Rhône, Frankrike, 13000
    - Rekrytering
    - Clairval's Hospital
- Finistère
  - Brest, Finistère, Frankrike, 29200
    - Rekrytering
    - Brest University Hospital
- Gironde
  - Bordeaux, Gironde, Frankrike, 33000
    - Rekrytering
    - Bordeaux University Hospital
- Haute-Garonne
  - Toulouse, Haute-Garonne, Frankrike, 31000
    - Rekrytering
    - Toulouse University Hospital
- Haute-Vienne
  - Limoges, Haute-Vienne, Frankrike, 87000
    - Rekrytering
    - Limoges University Hospital
- Ille-et-Vilaine
  - Rennes, Ille-et-Vilaine, Frankrike, 35000
    - Rekrytering
    - Rennes University Hospital
- Indre-et-Loire
  - Tours, Indre-et-Loire, Frankrike, 37000
    - Rekrytering
    - Tours University Hospital
- Loire-Atlantique
  - Nantes, Loire-Atlantique, Frankrike, 44000
    - Rekrytering
    - Nantes University Hospital
    - Huvudutredare:
      
      Romain BOURCIER, MD
- Maine et Loire
  - Angers, Maine et Loire, Frankrike, 49000
    - Rekrytering
    - Angers University Hospital
- Marne
  - Reims, Marne, Frankrike, 51100
    - Indragen
    - Reims University Hospital
- Meurthe-et-Moselle
  - Nancy, Meurthe-et-Moselle, Frankrike, 54000
    - Rekrytering
    - Nancy University Hospital
- Paris
  - Paris, Paris, Frankrike, 75000
    - Rekrytering
    - AP-HP La Pitié-Salpêtrière Hospital
  - Paris, Paris, Frankrike, 75000
    - Rekrytering
    - AP-HP Le Kremlin Bicêtre Hospital
  - Paris, Paris, Frankrike, 75000
    - Rekrytering
    - Rostchild Foundation Hospital
- Seine-Maritime
  - Rouen, Seine-Maritime, Frankrike, 76000
    - Rekrytering
    - Rouen University Hospital
- Somme
  - Amiens, Somme, Frankrike, 80000
    - Rekrytering
    - Amiens University Hospital
- Île-de-France Region
  - Paris, Île-de-France Region, Frankrike, 75674
    - Rekrytering
    - Ste Anne's Hospital
Nederländerna
- - Utrecht, Nederländerna, 3500
    - Avslutad
    - UMC Utrecht
Schweiz
- - Bern, Schweiz, 3000
    - Har inte rekryterat ännu
    - InselHospital Bern

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

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.

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Observationsmodeller: COHORT
Tidsperspektiv: PROSPECTIVE

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
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. Tidsram: 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 Tidsram: 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 Tidsram: 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

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Quality of life related to the growth of UIA. Tidsram: 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. Tidsram: 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. Tidsram: 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. Tidsram: 5 years	Incidence of growth, stratified by clinical, genetics or biological features.	5 years
Incidence of IA rupture Tidsram: 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. Tidsram: 5 years	Completion of standardized EQ5D questionnaire to measure quality of life patients	5 years
Construction of an automatized tool of AWE pattern Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Nantes University Hospital

Samarbetspartners

Centre Hospitalier St Anne

Utredare

Huvudutredare: Romain BOURCIER, MD, Nantes University Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

19 augusti 2019

Primärt slutförande (Beräknad)

15 mars 2031

Avslutad studie (Beräknad)

15 mars 2031

Studieregistreringsdatum

Först inskickad

9 september 2020

Först inskickad som uppfyllde QC-kriterierna

1 oktober 2020

Första postat (Faktisk)

8 oktober 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

25 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

RC20_0012

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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