Unruptured Brain Arteriovenous Malformation
Conditions
Keywords
Arteriovenous malformation, Perfusion disorders, Metabolism, Positon Emission Tomography, Neuropathology
Brief summary
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.
Detailed description
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.
Interventions
RADIATION18F-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.
OTHERNeuropsychological 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.
Sponsors
University Hospital, Montpellier
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Standardized Uptake Value (SUV) | 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) |
| Change in K1 Transfer Constant | 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 |
| Change in Ki Net Influx Rate Constant | 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 |
| Change in Cerebral Metabolic Rate of glucose (CMRglu) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Headache impact | 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. |
| Visual attention and processing speed | 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) |
| Cognitive flexibility and executive control | 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) |
| Inhibition and selective attention | 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 |
| Working memory | 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) |
| Global verbal episodic memory | 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) |
| Phonemic and semantic verbal fluency | 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 |
| Ecological executive functioning | 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) |
| Visual constructive abilities and visual memory | 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 |
| Visual attention and spatial exploration | 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. |
Countries
France
Contacts
CONTACTLucas RIBEIRO, Dr
Outcome results
None listed