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临床试验/NCT00450021
NCT00450021已完成1 期

Imaging of Cannabinoid CB(1) Receptors Using [11C] MePPEP

National Institute of Mental Health (NIMH)2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2007年3月19日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
25
试验地点
2
主要终点
Efficacy of novel PET tracer for DB! in Brain imaging.

研究概览

简要总结

This study will test a new radioactive tracer, [(11)C]MePPEP, for use in positron emission tomography (PET) imaging. The tracer is used to visualize cannabinoid receptors, proteins in the brain that mediate a variety of natural chemicals. These receptors may be important in behavioral diseases such as addiction, obesity and psychiatric diseases.

Healthy normal volunteers between 18 and 65 years of age may be eligible for this study.

Ten participants undergo whole body PET imaging to determine where the [(11)C]MePPEP tracer is distributed in the body in order to calculate radiation exposure from the tracer. Another 10 subjects undergo brain imaging with [(11)C]MePPEP to measure cannabinoid receptors in the brain.

All participants are evaluated with a medical history and physical examination, blood and urine tests and an electrocardiogram (ECG) before scanning. They then have a PET scan. For this procedure, a catheter (plastic tube) is placed in a vein in the arm through which the tracer is injected. A special mask is fitted to the head and attached to the bed to help keep the head in place during the scan. Subjects undergoing brain imaging also have a catheter placed in an artery in the wrist from which blood samples are collected during the procedure. The scan lasts about 2 to 2.5 hours.

Subjects undergoing brain imaging also have magnetic resonance imaging (MRI) within 1 year of the PET scan. For MRI, the subject lies on a bed that moves into the tubular scanner, wearing earplugs to protect the ears from loud noises that occur during the scan. The procedure takes about 1 hour.

详细描述

BRAIN IMAGING:

OBJECTIVE:

The central cannabinoid receptor, CB(1) 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 the G-protein coupled receptor family. The CB(1) is a target for drug therapy, including the use of an antagonist as an appetite suppressant. The central cannabinoid receptor CB(1) has never been visualized in humans. In collaboration with Eli Lilly, we developed a promising PET ligand for the CB(1) receptor: [(11)C]MePPEP. This study is known by Eli Lilly as H6O-MC-GCEB.

STUDY POPULATION:

In the current protocol, we wish to evaluate [(11)C]MePPEP in approximately 15 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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Efficacy of novel PET tracer for DB! in Brain imaging.

次要结局

  • Safety and radiation dosimetry of PET tracer [11C] MePPEP; Distribution and variance of CB1 receptors in the brain of healthy controls

研究者

研究点 (2)

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