Unruptured Brain Arteriovenous MalformationAPEMMAV-NRNCT07569887
Exploratory Study of Cerebral Perfusion and Metabolic Alterations and Neurocognitive Disorders in Patients With Unruptured Arteriovenous Malformations Before and After Surgical Treatment
A study testing 18F-FDG PET imaging and Neuropsychological Assessment in people with Unruptured Brain Arteriovenous Malformation, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unruptured Brain Arteriovenous Malformation
- What is being tested?
- 18F-FDG PET imaging and Neuropsychological Assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 and older
- Admitted for an unruptured arteriovenous malformation with a decision to proceed with surgery
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Montpellier
Montpellier, France, 34295
Lucas RIBEIRO, Dr, 0467337432 ext. +33, l-ribeiro@chu-montpellier.fr
Lucas RIBEIRO, Dr
About this study
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.
Read the 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.
- Being tested
- 18F-FDG PET imaging, Neuropsychological Assessment
- Keywords
- Arteriovenous malformation, Perfusion disorders, Metabolism, Positon Emission Tomography, Neuropathology
- Medical subject headings
- Arteriovenous Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Not described Receives: Radiation: 18F-FDG PET imaging; Other: Neuropsychological Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 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
Measured: Before and at 6 months after surgical treatment of unruptured arteriovenous malformation
Secondary outcomes (10)
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.
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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.
Measured: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start16 Jun 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unruptured Brain Arteriovenous MalformationStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569887
- Sponsor's protocol ID
- RECHMPL25_0330
- Acronym
- APEMMAV-NR
- Status last verified
- Jul 2026
- First submitted
- 21 Apr 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Cerebral Perfusion and Metabolic Alterations and Neurocognitive Disorders in Patients With Unruptured Arteriovenous Malformations Before and After Surgical Treatment
- ClinicalTrials.gov ID
- NCT07569887
- Acronym / sponsor ID
- APEMMAV-NR / RECHMPL25_0330
- Keywords
- Arteriovenous malformation, Perfusion disorders, Metabolism, Positon Emission Tomography, Neuropathology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Radiation: 18F-FDG PET imaging, Other: Neuropsychological Assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 18 and older
- Admitted for an unruptured arteriovenous malformation with a decision to proceed with surgery
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FDG PET imagingFor 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. | Radiation | Experimental arm |
| Neuropsychological AssessmentFor 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. | Other | Experimental arm |
Primary outcome
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)
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
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
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
10 secondary outcomes
Headache impact
Time frame: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Visual attention and processing speed
Time frame: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Cognitive flexibility and executive control
Time frame: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Inhibition and selective attention
Time frame: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Working memory
Time frame: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Global verbal episodic memory
Time frame: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Phonemic and semantic verbal fluency
Time frame: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Ecological executive functioning
Time frame: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Visual constructive abilities and visual memory
Time frame: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Visual attention and spatial exploration
Time frame: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-FDG PET imaging and Neuropsychological Assessment in people with Unruptured Brain Arteriovenous Malformation, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucas RIBEIRO, Dr (0467337432 ext. +33, l-ribeiro@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Standardized Uptake Value (SUV) (time frame: Before and at 6 months after surgical treatment of unruptured arteriovenous malformation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.