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NCT Number: NCT07569887

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Montpellier

Montpellier, France, 34295

Location status: Recruiting

Location contact

Lucas RIBEIRO, Dr

CONTACT

[email protected]

0467337432 ext. +33

Lucas RIBEIRO, Dr

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Change in Standardized Uptake Value (SUV)

    Time frame: 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)

  2. Change in K1 Transfer Constant

    Time frame: 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

  3. Change in Ki Net Influx Rate Constant

    Time frame: 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

  4. Change in Cerebral Metabolic Rate of glucose (CMRglu)

    Time frame: 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 outcomes

  1. Headache impact

    Time frame: 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.

  2. Visual attention and processing speed

    Time frame: 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)

  3. Cognitive flexibility and executive control

    Time frame: 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)

  4. Inhibition and selective attention

    Time frame: 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

  5. Working memory

    Time frame: 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)

  6. Global verbal episodic memory

    Time frame: 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)

  7. Phonemic and semantic verbal fluency

    Time frame: 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

  8. Ecological executive functioning

    Time frame: 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)

  9. Visual constructive abilities and visual memory

    Time frame: 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

  10. Visual attention and spatial exploration

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lucas RIBEIRO, Dr

CONTACT

[email protected]

0467337432 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: APEMMAV-NR

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 6, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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