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 mayo de 2026 actualizado 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Estimado)
10
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Lucas RIBEIRO, Dr
- Número de teléfono: +33 0467337432
- Correo electrónico: l-ribeiro@chu-montpellier.fr
Ubicaciones de estudio
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France
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Montpellier, France, Francia, 34295
- CHU de Montpellier
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Contacto:
- Lucas RIBEIRO, Dr
- Número de teléfono: +33 0467337432
- Correo electrónico: l-ribeiro@chu-montpellier.fr
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Investigador principal:
- Lucas RIBEIRO, Dr
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Brazo experimental
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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.
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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Standardized Uptake Value (SUV)
Periodo de tiempo: Before and at 6 months after surgical treatment of unruptured arteriovenous malformation
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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)
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Before and at 6 months after surgical treatment of unruptured arteriovenous malformation
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Change in K1 Transfer Constant
Periodo de tiempo: Before and at 6 months after surgical treatment of unruptured arteriovenous malformation
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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
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Before and at 6 months after surgical treatment of unruptured arteriovenous malformation
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Change in Ki Net Influx Rate Constant
Periodo de tiempo: Before and at 6 months after surgical treatment of unruptured arteriovenous malformation
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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
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Before and at 6 months after surgical treatment of unruptured arteriovenous malformation
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Change in Cerebral Metabolic Rate of glucose (CMRglu)
Periodo de tiempo: Before and at 6 months after surgical treatment of unruptured arteriovenous malformation
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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
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Before and at 6 months after surgical treatment of unruptured arteriovenous malformation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Headache impact
Periodo de tiempo: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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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.
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Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Visual attention and processing speed
Periodo de tiempo: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Visual attention and processing speed assessed by completion time on the Trail Making Test - Part A (TMT-A)
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Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Cognitive flexibility and executive control
Periodo de tiempo: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Cognitive flexibility and executive control assessed by completion time on the Trail Making Test - Part B (TMT-B)
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Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Inhibition and selective attention
Periodo de tiempo: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Inhibition and selective attention assessed by completion times and number of errors on the Stroop Test
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Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Working memory
Periodo de tiempo: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Working memory assessed by scores on the Digit Span subtest of the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV)
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Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Global verbal episodic memory
Periodo de tiempo: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Global verbal episodic memory assessed by scores on the 16-item Free Recall / Cued Recall test (RL/RI-16)
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Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Phonemic and semantic verbal fluency
Periodo de tiempo: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Phonemic and semantic verbal fluency assessed by the number of words produced on verbal fluency tests
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Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Ecological executive functioning
Periodo de tiempo: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Ecological executive functioning assessed by raw scores and composite indices on the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
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Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Visual constructive abilities and visual memory
Periodo de tiempo: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Visual constructive abilities and visual memory assessed by scores on the Rey-Osterrieth Complex Figure Test
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Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Visual attention and spatial exploration
Periodo de tiempo: Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Visual attention and spatial exploration assessed by the number of crossed-out targets, omissions, and their spatial distribution in the Bell Test.
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Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de mayo de 2026
Finalización primaria (Estimado)
1 de noviembre de 2028
Finalización del estudio (Estimado)
1 de noviembre de 2028
Fechas de registro del estudio
Enviado por primera vez
21 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
4 de mayo de 2026
Publicado por primera vez (Actual)
6 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
4 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Anomalías congénitas
- Anomalías cardiovasculares
- Malformaciones Vasculares
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Malformaciones arteriovenosas
- Disciplinas y actividades de comportamiento
- Pruebas psicológicas
- Pruebas neuropsicológicas
Otros números de identificación del estudio
- RECHMPL25_0330
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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