Imaging of Cannabinoid CB1 Receptors Using [18F]FMPEP-d2
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Efficacy of novel PET tracer for CB1 in brain imaging.
研究概览
简要总结
The purpose of this protocol is to measure brain CB1 receptors in the hope to better understand how they work, so that one day we can understand how the CB1 receptors are involved in psychiatric, neurological, and behavioral disorders.
详细描述
BRAIN IMAGING
Objective
The central cannabinoid receptor (CB1) is one of the most abundant neuromodulatory receptors in the brain. It is found on glutamatergic, dopaminergic and GABA-ergic synaptic terminals and belongs to G-protein coupled receptor family. The CB1 is a target for drug therapy, including the use of an antagonist as an appetite suppressant. The central cannabinoid receptor CB1 has never been visualized in humans. In collaboration with Eli Lilly, we developed a promising PET ligand for the CB1 receptor: [18F]FMPEP-d2 ((3R,5R)-5-(3-(fluoromethoxy)phenyl)-3-((R)-1-phenylethylamino)-1-(4-(trifluoromethyl)phenyl)pyrrolidin-2-one).
Study Population
In the current protocol, we wish to evaluate [18F]FMPEP-d2 in approximately 10 healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •INCLUSION CRITERIA:
- •All subjects must be healthy and aged 18-65 years, with history/physical exam, ECG, and laboratory tests within one year of the PET scan.
- •The volunteer must sign an informed consent form.
排除标准
- •Current psychiatric illness, substance abuse including marijuana use, or severe systemic disease based on history and physical exam.
- •Laboratory tests with clinically significant abnormalities or positive urine toxicology screen.
- •Prior participation in other research protocols in the last year such that radiation exposure would exceed the annual limits.
- •Pregnancy and breast feeding.
- •Claustrophobia.
- •Presence of ferromagnetic metal in the body or heart pacemaker.
- •Positive HIV test.
- •Employee of the investigative site or an immediate family member of an employee of the investigative site. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- •Employee of Eli Lilly and Company.
结局指标
主要结局
Efficacy of novel PET tracer for CB1 in brain imaging.
次要结局
- Distribution and variance of CB1 receptors in the brain of healthy controls.