About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 and older
Admitted for an unruptured arteriovenous malformation with a decision to proceed with surgery
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
18F-FDG PET imaging
RadiationFor 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 Assessment
Other interventionFor 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.
Treatment groups
Trial 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)
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
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
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
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.
Visual attention and processing speed
Visual attention and processing speed assessed by completion time on the Trail Making Test - Part A (TMT-A)
Cognitive flexibility and executive control
Cognitive flexibility and executive control assessed by completion time on the Trail Making Test - Part B (TMT-B)
Inhibition and selective attention
Inhibition and selective attention assessed by completion times and number of errors on the Stroop Test
Sponsors and contacts
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