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

4. mai 2026 oppdatert av: University Hospital, Montpellier
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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

10

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Frankrike
    • France
      • Montpellier, France, Frankrike, 34295
        • CHU de Montpellier
        • Ta kontakt med:
        • Hovedetterforsker:
          • Lucas RIBEIRO, Dr

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Eksperimentell arm
Stråling: 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.

Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Standardized Uptake Value (SUV)
Tidsramme: 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)
Before and at 6 months after surgical treatment of unruptured arteriovenous malformation
Change in K1 Transfer Constant
Tidsramme: 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
Before and at 6 months after surgical treatment of unruptured arteriovenous malformation
Change in Ki Net Influx Rate Constant
Tidsramme: 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
Before and at 6 months after surgical treatment of unruptured arteriovenous malformation
Change in Cerebral Metabolic Rate of glucose (CMRglu)
Tidsramme: 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
Before and at 6 months after surgical treatment of unruptured arteriovenous malformation

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Headache impact
Tidsramme: 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.
Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Visual attention and processing speed
Tidsramme: 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)
Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Cognitive flexibility and executive control
Tidsramme: 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)
Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Inhibition and selective attention
Tidsramme: 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
Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Working memory
Tidsramme: 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)
Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Global verbal episodic memory
Tidsramme: 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)
Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Phonemic and semantic verbal fluency
Tidsramme: 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
Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Ecological executive functioning
Tidsramme: 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)
Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Visual constructive abilities and visual memory
Tidsramme: 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
Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
Visual attention and spatial exploration
Tidsramme: 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.
Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospital, Montpellier

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. mai 2026

Primær fullføring (Antatt)

1. november 2028

Studiet fullført (Antatt)

1. november 2028

Datoer for studieregistrering

Først innsendt

21. april 2026

Først innsendt som oppfylte QC-kriteriene

4. mai 2026

Først lagt ut (Faktiske)

6. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RECHMPL25_0330

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