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

N/ANot Yet RecruitingNCT07569887

University Hospital, Montpellier10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Unruptured Brain Arteriovenous Malformation

Interventions

18F-FDG PET imagingRADIATION

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.

Neuropsychological AssessmentOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU de Montpellier

Montpellier, France, France

Outcomes

Primary Outcomes

Change in Standardized Uptake Value (SUV)

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)

Time frame: Before and at 6 months after surgical treatment of unruptured arteriovenous malformation

Change in K1 Transfer Constant

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

Time frame: Before and at 6 months after surgical treatment of unruptured arteriovenous malformation

Change in Ki Net Influx Rate Constant

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

Time frame: Before and at 6 months after surgical treatment of unruptured arteriovenous malformation

Change in Cerebral Metabolic Rate of glucose (CMRglu)

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

Time frame: Before and at 6 months after surgical treatment of unruptured arteriovenous malformation

Central Contacts

Lucas RIBEIRO, Dr

CONTACT

0467337432 l-ribeiro@chu-montpellier.fr

Data from ClinicalTrials.gov

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Secondary Outcomes

Headache impact

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.