Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)
Purpose
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.
Conditions
- Radiotracer
- Hypertension
- Cholesterol
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Participants without any known adrenal pathology as normal controls for radiation dosimetry purposes
Exclusion Criteria
- 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
Study Design
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other 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. |
|
Recruiting Locations
More Details
- NCT ID
- NCT04532489
- Status
- Recruiting
- Sponsor
- Benjamin Viglianti
Detailed Description
Following the results of radiation dosimetry from this study then next steps will be taken for groups 2 & 3 using hormone manipulation.