NCT02720354已完成1 期
A Phase I Study of a Novel Tracer for Positron Emission Tomography "PET" Myocardial Perfusion Imaging "MPI"
Synektik S.A.0 个研究点目标入组 12 人开始时间: 2016年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 主要终点
- Measurement of absorbed radiation dose for all target organs in megabecquerel (the activity of a quantity of radioactive material in which one nucleus decays per second).
研究概览
简要总结
[11C]-dimethyl-diphenyl ammonium ([11C]-DMDPA) - A Phase I, Open-label, Safety and Tolerability, Radiation Dosimetry, Biodistribution, First-in-Human Study of a Novel 11C-labeled Tracer for Positron Emission Tomography Myocardial Perfusion Imaging
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 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •body mass index (BMI) between 18.0 and 30.0 kg/m2
- •good health
- •written informed consent
排除标准
- •subject receiving medication
- •a blood transfusion in the 4 weeks prior to screening
- •positive alcohol blood test
- •Subjects who suffer from claustrophobia
- •Subjects who have had a clinically significant illness
- •Subjects exposed to radiation within 12 months prior to screening
研究组 & 干预措施
A single Intravenous bolus injection
Experimental
A single Intravenous bolus injection of 11C[DMDPA]
干预措施: [11C]-DMDPA (Other)
结局指标
主要结局
Measurement of absorbed radiation dose for all target organs in megabecquerel (the activity of a quantity of radioactive material in which one nucleus decays per second).
时间窗: within 80 minutes
次要结局
未报告次要终点
研究者
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