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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Unruptured Brain Arteriovenous Malformation
• Intervention / Treatment: Radiation: 18F-FDG PET imaging; Other: Neuropsychological Assessment

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lucas RIBEIRO, Dr; Phone Number: +33 0467337432; Email: l-ribeiro@chu-montpellier.fr

Study Locations

• France
  • France
    • Montpellier, France, France, 34295
      • CHU de Montpellier
      • Contact: Lucas RIBEIRO, Dr; Phone Number: +33 0467337432; Email: l-ribeiro@chu-montpellier.fr
      • Principal Investigator: Lucas RIBEIRO, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental arm

Radiation: 18F-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.; Other: Neuropsychological 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	Before and at 6 months after surgical treatment of unruptured arteriovenous malformation

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Metabolism; Arteriovenous malformation; Neuropathology; Positon Emission Tomography; Perfusion disorders
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Arteriovenous Malformations; Behavioral Disciplines and Activities; Psychological Tests; Neuropsychological Tests
• Other Study ID Numbers: RECHMPL25_0330

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No