F-18-AV-45 Uptake, Spot Sign Presence and Cerebral Amyloid Angiopathy (CAA) in Primary Intracranial Hemorrhage (ICH)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Type of Bleed
研究概览
简要总结
Florbetapir F 18 is an experimental radioactive drug that may allow doctors to image changes in the brain using a PET (Positron Emission Tomography) scanner. The purpose of this study is to evaluate the imaging characteristics of, Florbetapir F 18 (also known as 18F-AV-45) in patients who have previously undergone bleeding in their brains. Florbetapir F 18 binds to amyloid-ß peptide (Aß) that accumulates in the brains of patients with bleeding. These accumulations are called amyloid plaques and when extensive are labeled cerebral amyloid angiopathy (CAA). Florbetapir F 18 sticks to the amyloid plaques in the brain and emits a low level of gamma rays which can be detected by a PET camera.
MRI detected microbleeds have been identified as markers of clinically silent hemorrhage from bleeding-prone vessels. Another imaging marker of vessel damage and risk of bleeding is the spot sign (SS). Finally, certain genetic signatures (ApoE genotype) have been shown to be associated with Aß deposition in the brain or predispose patients to higher risks of bleeding. This research study will explore the interactions of these factors and understand the physiology of intracerebral bleeding.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Prior intracranial hemorrhage at least 3 months prior
- •Patients >18 years
排除标准
- •Modified Rankin score >
- •Clinically significant medical comorbidities which in the opinion of the investigator might pose a potential safety risk to the subject.
- •Women of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception.
- •Have a history of relevant severe drug allergy or hypersensitivity
- •Patients who withdraw consent. Age and gender-matched microbleed patients previously demonstrating MRI microbleeds without prior macrobleeds will be recruited from stroke clinic
结局指标
主要结局
Type of Bleed
时间窗: 2-3 weeks
Patients will be divided into micro- and macro- bleeders based on MRI detected microhemorhage pattern. Processing of each patient will take 2-3 weeks.
Spot Sign Status
时间窗: 2-3 weeks
They will be further subdivided by spot sign status into positive or negative.
Amyloid uptake
时间窗: 2-3 weeks
次要结局
- ApoE genotype(2-3 weeks)
