Study of Cerebral Vascular Reserve Using Pharmacological Testing With Acetazolamide: A Non-Inferiority Study of PET Method Compared to Conventional Reference Scintigraphy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- diagnostic performance of the 18F-FDG PET
研究概览
简要总结
This study compares two methods for assessing brain blood flow. PET scan will be use with a drug called Acetazolamide and compare its effectiveness to the standard scintigraphy method. The goal is to see if the PET scan is just as good as the traditional method in measuring how well the brain's blood vessels respond to the drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Chronic stenosing cerebral vascular pathology (stenosis > 70% on Doppler examination or angiography).
- •Patient aged over 18 years.
- •Patient who has voluntarily agreed to participate in the study and has signed the written informed consent.
- •Patient affiliated with a social security system.
排除标准
- •Patient with stenosis less than 70% on Doppler examination or angiography.
- •Patient with a contraindication to 18F-FDG PET examinations: severe claustrophobia, poorly controlled diabetes during 18F-FDG PET examinations (fasting capillary blood glucose ≥ 11 mmol/L).
- •Patient with a contraindication to scintigraphy.
- •Patient with an allergy to sulfonamides (Acetazolamide DIAMOX®).
- •Patient enrolled in another clinical study with a specified exclusion period.
- •Minor patient.
- •Patient unable to give informed consent.
- •Vulnerable individuals
结局指标
主要结局
diagnostic performance of the 18F-FDG PET
时间窗: 12 months
The primary endpoint is the sensitivity of the examination in detecting a decrease in cerebral vascular reserve (CVR). The presence or absence of a decrease in CVR for each patient will be determined by clinical consensus, based in particular on spontaneous follow-up (clinical progression, cerebral ischemic episodes, etc.) and/or on the progression after revascularization in cases where it is performed.
次要结局
- contribution of late 18F-FDG PET metabolic information(12 months)