Study of the Kinetics, Dosimetry and Safety of [18F]F-AraG, a Positron Emission Tomography Tracer for Imaging the Activation of the Immune System in Healthy Humans
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Visualize biodistribution of the PET tracer [18F]F-AraG
研究概览
简要总结
The goal of this study is to visualize biodistribution of a PET tracer called [18F]F-AraG through time in healthy human volunteers.
详细描述
A positron emission tomography (PET) imaging tracer will be intravenously injected into healthy human volunteers who provide informed consent. Following injection of this tracer each volunteer will have four whole-body PET scans inside a PET scanner to obtain images of tracer biodistribution at four different time points. This will allow studying the kinetics of the tracer as well analysis of tracer dosimetry. Safety of the tracer will also be analyzed in each volunteer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy human subjects without history of chronic disease or at present an acute disease will be included.
- •Ability to abide by the study conditions is also a requirement for inclusion.
排除标准
- •Individuals under the age of 18 years and pregnant women will be excluded from the [18F]F-AraG imaging studies.
- •Women who are breast-feeding will be excluded from the study.
- •Individuals unable to provide informed consent will be excluded.
研究组 & 干预措施
18F-FAraG
A single dose intravenous injection of 18F-FAraG followed by PET scanning.
干预措施: [18F]F-AraG (Drug)
结局指标
主要结局
Visualize biodistribution of the PET tracer [18F]F-AraG
时间窗: 1 day
Whole-body \[18F\]F-AraG PET scans will be performed at 4 different time points following intravenous injection of the PET tracer. Four whole-body images will be obtained that will reveal biodistribution of \[18F\]F-AraG at 4 different consecutive time points after intravenous injection.
Analyze human dosimetry of [18F]F-AraG
时间窗: 1 day
Time-Activity curves will be graphed by measuring activity in various organs at the 4 time points after tracer injection. From these time activity curves absorbed radiation will be calculated.
Assess acute safety of intravenously injected trace dose of [18F]F-AraG
时间窗: 8 days
Blood and urine samples may be collected at baseline and at 1 and 8 days after injection of \[18F\]F-AraG to perform metabolic panel, CBC and urine analysis. Vital signs and EKG will be measured and recorded at baseline, within 3 hours after tracer injection and at 1 and 8 days after tracer injection.
次要结局
未报告次要终点