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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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.

  • Neuropsychological Assessment

    Other intervention

    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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Experimental armExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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.

Time frame
Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
2

Visual attention and processing speed

Visual attention and processing speed assessed by completion time on the Trail Making Test - Part A (TMT-A)

Time frame
Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
3

Cognitive flexibility and executive control

Cognitive flexibility and executive control assessed by completion time on the Trail Making Test - Part B (TMT-B)

Time frame
Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
4

Inhibition and selective attention

Inhibition and selective attention assessed by completion times and number of errors on the Stroop Test

Time frame
Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation

Other outcomes

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