Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in [18F]FNP-59 chemistry uptake as measured by the standardized uptake value (SUV) based gland segmentation
研究概览
简要总结
This 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. Some participants are healthy normal subjects but have undergone interventions to manipulate hormones while other participants have known adrenal pathology.
详细描述
Groups 2 & 3 used hormone manipulation using information gathered from Group 1 which identified radiation dosimetry and optimal uptake time.
Group 4 (added to the study later) includes participants with known adrenal pathology. They will not have study associated hormone manipulation.
All groups will be given a radio-tracer and PET/CT scans.
The researchers believe that a fluorine-18 analogue of NP-59, [18F]FNP-59, would greatly improve the imaging characteristics, by providing a PET imaging cholesterol analogue with significantly improved radiation dosimetry, and improved localization / sensitivity / specificity without concern of thyroid exposure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dexamethasone (Group 2)
Participants will undergo an FNP-59 scan on day 0 in the am. Participants will then take
1 mg dexamethasone 2x a day for 3 days to suppress cortisol production. Participants will then have a second FNP-59 scan on day 4 in the am.
干预措施: Dexamethasone (Group 2) (Drug)
Dexamethasone (Group 2)
Participants will undergo an FNP-59 scan on day 0 in the am. Participants will then take
1 mg dexamethasone 2x a day for 3 days to suppress cortisol production. Participants will then have a second FNP-59 scan on day 4 in the am.
干预措施: PET/CT Scan with FNP-59 (Combination Product)
Cosyntropin (Group 3)
Participants will undergo an FNP-59 scan on day 0 in the am. On day 4 the participant will arrive for imaging. Cosyntropin, 250 micro-gm will be administered IV. Five minutes following administration FNP-59 will be given. Following uptake of FNP-59 imaging will occur.
干预措施: Cosyntropin (Group 3) (Drug)
Cosyntropin (Group 3)
Participants will undergo an FNP-59 scan on day 0 in the am. On day 4 the participant will arrive for imaging. Cosyntropin, 250 micro-gm will be administered IV. Five minutes following administration FNP-59 will be given. Following uptake of FNP-59 imaging will occur.
干预措施: PET/CT Scan with FNP-59 (Combination Product)
Adrenal pathology (Group 4)
Whole-body PET/CT scans will be done on 4 patients at 1 hr and the other 4 patients at 6 hours. All the patients will have a whole-body PET/CT scan at 3 hours.
干预措施: PET/CT Scan with FNP-59 (Combination Product)
结局指标
主要结局
Change in [18F]FNP-59 chemistry uptake as measured by the standardized uptake value (SUV) based gland segmentation
时间窗: Day 0, Day 4
SUV will be reported. Both maximal and average SUVs will be calculated
次要结局
- PET/CT image uptake score as measured by investigator visual assessment for each volume of interest (VOI)(Day 4)
研究者
Benjamin Viglianti
Assistant Professor of Radiology
University of Michigan