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

22. september 2026 oppdatert 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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).

Studietype

Observasjonsmessig

Registrering (Antatt)

1000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Frankrike
      • Besançon, Frankrike
        • Rekruttering
        • CHU de Besançon
        • Hovedetterforsker:
          • Alessandra BIONDI
        • Ta kontakt med:
      • Caen, Frankrike
        • Rekruttering
        • CHU de Caen
        • Ta kontakt med:
        • Hovedetterforsker:
          • Charlotte BARBIER
      • Clermont-Ferrand, Frankrike
        • Rekruttering
        • CHU de Clermont Ferrand
        • Ta kontakt med:
        • Hovedetterforsker:
          • Emmanuel CHABERT
      • Colmar, Frankrike
        • Har ikke rekruttert ennå
        • Hôpitaux Civils de Colmar
        • Ta kontakt med:
        • Hovedetterforsker:
          • Pablo Ariel LEBEDINSKY
      • Dijon, Frankrike
        • Rekruttering
        • CHU Dijon
        • Ta kontakt med:
        • Hovedetterforsker:
          • Pierre THOUANT
      • Poitiers, Frankrike
        • Rekruttering
        • CHU de Poitiers
        • Hovedetterforsker:
          • Samy BOUCEBCI
        • Ta kontakt med:
      • Saint-Etienne, Frankrike
        • Rekruttering
        • CHU de saint Etienne
        • Hovedetterforsker:
          • Marina SACHET
        • Ta kontakt med:
      • Strasbourg, Frankrike
        • Rekruttering
        • CHU de Strasbourg
        • Hovedetterforsker:
          • Raoul POP
        • Ta kontakt med:
      • Suresnes, Frankrike
        • Rekruttering
        • Hôpital Foch
        • Hovedetterforsker:
          • Arturo CONSOLI
        • Ta kontakt med:
      • Toulon, Frankrike
        • Rekruttering
        • St Anne HIA
        • Ta kontakt med:
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, Frankrike, 13000
        • Rekruttering
        • Clairval's Hospital
    • Finistère
      • Brest, Finistère, Frankrike, 29200
        • Rekruttering
        • Brest University Hospital
    • Gironde
      • Bordeaux, Gironde, Frankrike, 33000
        • Rekruttering
        • Bordeaux University Hospital
    • Haute-Garonne
      • Toulouse, Haute-Garonne, Frankrike, 31000
        • Rekruttering
        • Toulouse University Hospital
    • Haute-Vienne
      • Limoges, Haute-Vienne, Frankrike, 87000
        • Rekruttering
        • Limoges University Hospital
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, Frankrike, 35000
        • Rekruttering
        • Rennes University Hospital
    • Indre-et-Loire
      • Tours, Indre-et-Loire, Frankrike, 37000
        • Rekruttering
        • Tours University Hospital
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, Frankrike, 44000
        • Rekruttering
        • Nantes University Hospital
        • Hovedetterforsker:
          • Romain BOURCIER, MD
    • Maine et Loire
      • Angers, Maine et Loire, Frankrike, 49000
        • Rekruttering
        • Angers University Hospital
    • Marne
      • Reims, Marne, Frankrike, 51100
        • Tilbaketrukket
        • Reims University Hospital
    • Meurthe-et-Moselle
      • Nancy, Meurthe-et-Moselle, Frankrike, 54000
        • Rekruttering
        • Nancy University Hospital
    • Paris
      • Paris, Paris, Frankrike, 75000
        • Rekruttering
        • AP-HP La Pitié-Salpêtrière Hospital
      • Paris, Paris, Frankrike, 75000
        • Rekruttering
        • AP-HP Le Kremlin Bicêtre Hospital
      • Paris, Paris, Frankrike, 75000
        • Rekruttering
        • Rostchild Foundation Hospital
    • Seine-Maritime
      • Rouen, Seine-Maritime, Frankrike, 76000
        • Rekruttering
        • Rouen University Hospital
    • Somme
      • Amiens, Somme, Frankrike, 80000
        • Rekruttering
        • Amiens University Hospital
    • Île-de-France Region
      • Paris, Île-de-France Region, Frankrike, 75674
        • Rekruttering
        • Ste Anne's Hospital
  • Nederland
      • Utrecht, Nederland, 3500
        • Fullført
        • UMC Utrecht
  • Sveits
      • Bern, Sveits, 3000
        • Har ikke rekruttert ennå
        • InselHospital Bern

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Quality of life related to the growth of UIA.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 5 years

Incidence of growth, stratified by clinical, genetics or biological features.
5 years
Incidence of IA rupture
Tidsramme: 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.
Tidsramme: 5 years

Completion of standardized EQ5D questionnaire to measure quality of life patients
5 years
Construction of an automatized tool of AWE pattern
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Nantes University Hospital

Samarbeidspartnere

Centre Hospitalier St Anne

Etterforskere

  • Hovedetterforsker: Romain BOURCIER, MD, Nantes University Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

19. august 2019

Primær fullføring (Antatt)

15. mars 2031

Studiet fullført (Antatt)

15. mars 2031

Datoer for studieregistrering

Først innsendt

9. september 2020

Først innsendt som oppfylte QC-kriteriene

1. oktober 2020

Først lagt ut (Faktiske)

8. oktober 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • RC20_0012

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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