A Principal, Prospective, Open-label Biopsy Study to Validate Detection of Cerebral Cortical Amyloid With Flutemetamol (18F) Injection in Normal Pressure Hydrocephalus (NPH) Subjects.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the "Cerebellum" (CER) as the Reference Region.
研究概览
简要总结
To determine the level of association between the quantitative estimates of brain uptake of [18F]flutemetamol and the quantitative immunohistochemical and histochemistry estimates of amyloid levels in frontal lobe biopsy samples obtained from subjects during shunt placement for NPH.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is at least 50 years of age.
- •The subjects' general health is adequate to comply with study procedures.
- •The subject has been scheduled for a shunt placement procedure for the treatment of NPH.
排除标准
- •The subject has a contraindication for MRI or PET.
- •The subject is pregnant or lactating.
- •The subject has a known or suspected hypersensitivity/allergy to [18F]flutemetamol or to any of the excipients.
- •The subject has participated in any clinical study using an investigational agent within 30 days of dosing.
研究组 & 干预措施
Arm 1
干预措施: [18F]Flutemetamol (Drug)
结局指标
主要结局
Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the "Cerebellum" (CER) as the Reference Region.
时间窗: Post flutemetamol Injection
The level of association between the quantitative estimates of brain uptake of \[18F\]flutemetamol and the quantitative immunohistochemical estimates of amyloid levels in biopsy samples obtained during shunt placement in patients who have Normal Pressure Hydrocephalus (NPH). The quantitative estimates of brain uptake of \[18F\]flutemetamol (SUVR) will be made from the analysis of PET images.
次要结局
- Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the "Pons" as the Reference Region.(Post flutemetamol administration)