Exploratory Study of Cerebral Perfusion and Metabolic Alterations and Neurocognitive Disorders in Patients With Unruptured Arteriovenous Malformations Before and After Surgical Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Standardized Uptake Value (SUV)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 and older
- •Admitted for an unruptured arteriovenous malformation with a decision to proceed with surgery
排除标准
- •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
研究组 & 干预措施
Experimental arm
干预措施: 18F-FDG PET imaging (Radiation)
Experimental arm
干预措施: Neuropsychological Assessment (Other)
结局指标
主要结局
Change in Standardized Uptake Value (SUV)
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
次要结局
- 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)
- Global verbal episodic memory(Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation)
- Phonemic and semantic verbal fluency(Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation)
- Ecological executive functioning(Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation)
- Visual constructive abilities and visual memory(Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation)
- Visual attention and spatial exploration(Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation)