Exploratory Study of Cerebral Perfusion and Metabolic Alterations and Neurocognitive Disorders in Patients With Unruptured Arteriovenous Malformations Before and After Surgical Treatment (APEMMAV-NR)
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Lucas RIBEIRO, Dr
- 电话号码:+33 0467337432
- 邮箱:l-ribeiro@chu-montpellier.fr
学习地点
-
-
France
-
Montpellier、France、法国、34295
- CHU de Montpellier
-
接触:
- Lucas RIBEIRO, Dr
- 电话号码:+33 0467337432
- 邮箱:l-ribeiro@chu-montpellier.fr
-
首席研究员:
- Lucas RIBEIRO, Dr
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:实验臂
|
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.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Standardized Uptake Value (SUV)
大体时间: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
大体时间: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
大体时间: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)
大体时间: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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Headache impact
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
18F-FDG PET imaging的临床试验
-
University of AdelaideCentral Adelaide Local Health Network Incorporated完全的
-
Rigshospitalet, DenmarkCopenhagen University Hospital at Herlev招聘中
-
Peking University First Hospital招聘中
-
Fifth Affiliated Hospital, Sun Yat-Sen University招聘中