Cholesterol, Hypertension, Radiotracer
Conditions
Brief summary
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.
Detailed description
Following the results of radiation dosimetry from this study then next steps will be taken for groups 2 & 3 using hormone manipulation.
Interventions
DRUGFNP-59
FNP-59, a radiotracer, is administered for PET/CT scans.
Sponsors
Benjamin Viglianti
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uptake for [18F]FNP-59 in the adrenal glands using the standardized uptake value (SUV) based on gland segmentation | Day 0 | SUV will be reported. Both maximal and average SUVs will be calculated |
Countries
United States
Contacts
Primary ContactJim Pool
Outcome results
None listed