Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Uptake for [18F]FNP-59 in the adrenal glands using the standardized uptake value (SUV) based on gland segmentation
研究概览
简要总结
This exploratory, first-in-man, phase 0 study will evaluate the feasibility of using a sub-therapeutic dose of a fluorine-18 analogue of NP-59 ([18F]FNP-59) to image the adrenal gland in healthy normal subjects. The researchers believe that [18F]FNP-59 would greatly improve the imaging characteristics, by providing a PET imaging cholesterol analogue with significantly improved radiation dosimetry.
详细描述
Following the results of radiation dosimetry from this study then next steps will be taken for groups 2 & 3 using hormone manipulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Participants without any known adrenal pathology as normal controls for radiation dosimetry purposes
排除标准
- •Pregnancy
- •Unable to do imaging
- •Body weight greater than 400 lbs (181 Kg)
- •Prisoners are not eligible
- •Subjects unable to provide own consent are not eligible
- •Current use of steroids, Oral contraceptives (OCP), spironolactone, estrogen, androgen, progesterone, Angiotensin-converting enzyme (ACE inhibitors)/ Angiotensin II receptor blockers (ARBs), or supplements that are hormone analogues.
- •Known adrenal pathology
研究组 & 干预措施
Group 1
These subjects, 6 planned (3 male, 3 female), will be to obtain normal tissue distribution of [18F]NP-59 and confirm calculated radiation dosimetry and optimal uptake time.
干预措施: FNP-59 (Drug)
结局指标
主要结局
Uptake for [18F]FNP-59 in the adrenal glands using the standardized uptake value (SUV) based on gland segmentation
时间窗: Day 0
SUV will be reported. Both maximal and average SUVs will be calculated
次要结局
未报告次要终点
研究者
Benjamin Viglianti
Assistant Professor of Radiology
University of Michigan