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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-FDG PET imaging | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation |
| Visual attention and processing speed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucas RIBEIRO, Dr | Contact | 0467337432 | +33 | l-ribeiro@chu-montpellier.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Montpellier | Recruiting | Montpellier | France | 34295 | France |
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| Neuropsychological Assessment | Other | 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. |
|
| Before and at 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| ID | Term |
|---|---|
| D001165 | Arteriovenous Malformations |
| ID | Term |
|---|---|
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| ID | Term |
|---|---|
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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