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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 de maio de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

10

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • França
    • France
      • Montpellier, France, França, 34295
        • CHU de Montpellier
        • Contato:
        • Investigador principal:
          • Lucas RIBEIRO, Dr

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Braço experimental
Radiação: 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.

Outro: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Standardized Uptake Value (SUV)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Headache impact
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University Hospital, Montpellier

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de maio de 2026

Conclusão Primária (Estimado)

1 de novembro de 2028

Conclusão do estudo (Estimado)

1 de novembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

21 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de maio de 2026

Primeira postagem (Real)

6 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • RECHMPL25_0330

Plano para dados de participantes individuais (IPD)

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INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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