NCT07569887

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
31mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
May 2026Nov 2028

First Submitted

Initial submission to the registry

April 21, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

2.5 years

First QC Date

April 21, 2026

Last Update Submit

May 4, 2026

Conditions

Unruptured Brain Arteriovenous Malformation

Keywords

Arteriovenous malformationPerfusion disordersMetabolismPositon Emission TomographyNeuropathology

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (10)

  • Headache impact

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

  • Visual attention and processing speed

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

  • Cognitive flexibility and executive control

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

  • Inhibition and selective attention

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

  • Working memory

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

  • +5 more secondary outcomes

Study Arms (1)

Experimental arm

EXPERIMENTAL
Radiation: 18F-FDG PET imagingOther: Neuropsychological Assessment

Interventions

18F-FDG PET imagingRADIATION

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.

Experimental arm
Neuropsychological AssessmentOTHER

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.

Experimental arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 and older
  • Admitted for an unruptured arteriovenous malformation with a decision to proceed with surgery

You may not qualify if:

  • 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)
  • Failure to obtain written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Montpellier

Montpellier, France, 34295, France

Location

MeSH Terms

Conditions

Arteriovenous Malformations

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Vascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Central Study Contacts

Lucas RIBEIRO, Dr

CONTACT

0467337432l-ribeiro@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2026

First Posted

May 6, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

May 6, 2026

Record last verified: 2026-05

Locations

FR(1)