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Exploratory Study of Cerebral Perfusion and Metabolic Alterations and Neurocognitive Disorders in Patients With Unruptured Arteriovenous Malformations Before and After Surgical Treatment (APEMMAV-NR)

4 mai 2026 mis à jour par: University Hospital, Montpellier
The goal of the clinical trial is to describe perfusion and metabolic alterations in different brain regions before and six months after surgical treatment of arteriovenous malformations in adult patients with unruptured arteriovenous malformations.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

Unruptured cerebral arteriovenous malformations are a potentially life-threatening condition and the third leading cause of intracerebral hemorrhage in young adults. Approximately two-thirds of patients with arteriovenous malformations experience a rupture leading to intracranial haemorrhage or develop progressive neurological symptoms or deficits. To date, decisions regarding interventional treatment of unruptured arteriovenous malformations are based on the characteristics of the arteriovenous malformation (size, location, etc.).However, the treatment of these arteriovenous malformations remains controversial in the literature, as the morbidity and mortality associated with intervention may exceed those the malformation's natural history. Furthermore, characteristics of arteriovenous malformations observed during examinations (size, hemodynamic patterns, vascular components) are often insufficient to predict spontaneous evolution, haemorrhagic risk, and associated symptoms.

Studies suggest that neurological symptoms may be linked to impaired cerebral perfusion and metabolism, particularly through hypoperfusion in the peri-arteriovenous malformation region or peri-lesional oedema. However, the results of these previous studies remain limited and of little significance.

The proposed project aims to establish a cohort over a 16-month period in order to study in detail the metabolic and perfusion alterations associated with arteriovenous malformations, as well as their neurocognitive and psychological impacts, with the aim of improving the pathophysiology understanding and treatment of these malformations.

Type d'étude

Interventionnel

Inscription (Estimé)

10

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • France
    • France
      • Montpellier, France, France, 34295
        • CHU de Montpellier
        • Contact:
        • Chercheur principal:
          • Lucas RIBEIRO, Dr

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Adults aged 18 and older
  • Admitted for an unruptured arteriovenous malformation with a decision to proceed with surgery

Exclusion Criteria:

  • Patients who refuse surgical treatment for arteriovenous malformation
  • Contraindications to 18F-FDG PET (uncontrolled diabete)
  • Patients' inability to lie still for 40 minutes
  • Patients with a confirmed diagnosis of neurodegenerative or psychiatric disorders
  • Pregnant or breastfeeding women (Article L.1121-5 of the French Public Health Code)
  • Persons deprived of their liberty by judicial or administrative decision (Article L.1121-6 of the French Public Health Code)
  • Persons who are subject to legal protection measures or who are unable to express their consent (guardianship, curatorship, judicial protection; Article L.1121-8 of the French Public Health Code)
  • Not affiliated with a social security scheme or beneficiary of such a scheme (Article L.1121-8-1 of the French Public Health Code)
  • Persons participating in another study that includes an ongoing exclusion period (Article L.1121-12 of the French Public Health Code)
  • Failure to obtain written informed consent

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Bras expérimental
Radiation: 18F-FDG PET imaging

For the 18F-FDG (fluorodeoxyglucose labelled with fluorine-18) PET scan, a dynamic protocol with the radiopharmaceutical injected directly under the scanner.

The dose injected will be the same as that used in routine clinical practice, i.e. calculated based on the patient's weight.

The patient must fast for 6 hours prior to the examination. The total duration of the dynamic PET scan is estimated at approximately 1 hour 30 minutes.

Autre: Neuropsychological Assessment
For the neuropsychological assessment, a series of standardised tests, validated for the assessment of cognitive functions, will be administered. This assessment will be carried out by neuropsychologists trained in the use of these tests and who administer them as part of their routine practice, or by a trained physiatrist specialising in disorders of the central nervous system. The neuropsychological assessment is expected to take 2 to 3 hours per visit for the patient.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Standardized Uptake Value (SUV)
Délai: Before and at 6 months after surgical treatment of unruptured arteriovenous malformation
Changes in Standardized Uptake Value (SUV) measured by 18F-FDG positron emission tomography (PET) in different brain regions (arteriovenous malformation region, arteriovenous malformation hemisphere including the arteriovenous malformation region, arteriovenous malformation hemisphere excluding the arteriovenous malformation region, contralateral hemisphere)
Before and at 6 months after surgical treatment of unruptured arteriovenous malformation
Change in K1 Transfer Constant
Délai: Before and at 6 months after surgical treatment of unruptured arteriovenous malformation
Change in the K1 transfer constant, representing the transfer of the tracer from the plasma compartment to the tissue compartment, measured by 18F-FDG positron emission tomography (PET) measured in different brain regions (arteriovenous malformation region, arteriovenous malformation hemisphere including the arteriovenous malformation region, arteriovenous malformation hemisphere excluding the arteriovenous malformation region, contralateral hemisphere). Unit : mL.g-1.min-1
Before and at 6 months after surgical treatment of unruptured arteriovenous malformation
Change in Ki Net Influx Rate Constant
Délai: Before and at 6 months after surgical treatment of unruptured arteriovenous malformation
Change in Ki net influx rate constant measured by 18F-FDG positron emission tomography (PET) in different brain regions (arteriovenous malformation region, arteriovenous malformation hemisphere including the arteriovenous malformation region, arteriovenous malformation hemisphere excluding the arteriovenous malformation region, contralateral hemisphere). Unit : mL.g-1.min-1
Before and at 6 months after surgical treatment of unruptured arteriovenous malformation
Change in Cerebral Metabolic Rate of glucose (CMRglu)
Délai: Before and at 6 months after surgical treatment of unruptured arteriovenous malformation
Change in cerebral metabolic rate of glucose (CMRglu) measured by 18F-FDG positron emission tomography (PET) in different brain regions (arteriovenous malformation region, arteriovenous malformation hemisphere including the arteriovenous malformation region, arteriovenous malformation hemisphere excluding the arteriovenous malformation region, contralateral hemisphere). Unit : µmol.100g-¹.min-¹
Before and at 6 months after surgical treatment of unruptured arteriovenous malformation

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Headache impact
Délai: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Headache impact assessed by the total score on the Headache Impact Test - 6 items (HIT-6) Total score between 36 and 78. A higher score indicates a greater functional impact.
Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Visual attention and processing speed
Délai: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Visual attention and processing speed assessed by completion time on the Trail Making Test - Part A (TMT-A)
Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Cognitive flexibility and executive control
Délai: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Cognitive flexibility and executive control assessed by completion time on the Trail Making Test - Part B (TMT-B)
Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Inhibition and selective attention
Délai: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Inhibition and selective attention assessed by completion times and number of errors on the Stroop Test
Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Working memory
Délai: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Working memory assessed by scores on the Digit Span subtest of the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV)
Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Global verbal episodic memory
Délai: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Global verbal episodic memory assessed by scores on the 16-item Free Recall / Cued Recall test (RL/RI-16)
Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Phonemic and semantic verbal fluency
Délai: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Phonemic and semantic verbal fluency assessed by the number of words produced on verbal fluency tests
Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Ecological executive functioning
Délai: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Ecological executive functioning assessed by raw scores and composite indices on the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Visual constructive abilities and visual memory
Délai: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Visual constructive abilities and visual memory assessed by scores on the Rey-Osterrieth Complex Figure Test
Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Visual attention and spatial exploration
Délai: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Visual attention and spatial exploration assessed by the number of crossed-out targets, omissions, and their spatial distribution in the Bell Test.
Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University Hospital, Montpellier

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 mai 2026

Achèvement primaire (Estimé)

1 novembre 2028

Achèvement de l'étude (Estimé)

1 novembre 2028

Dates d'inscription aux études

Première soumission

21 avril 2026

Première soumission répondant aux critères de contrôle qualité

4 mai 2026

Première publication (Réel)

6 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • RECHMPL25_0330

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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