Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)
Benjamin Viglianti
Summary
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.
Description
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 /…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria (Groups 2 \& 3): * Participants without any known adrenal pathology as normal controls for undergoing endocrine manipulation Exclusion Criteria (Groups 2 \& 3): * 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…
Interventions
- DrugDexamethasone (Group 2)
Participants will take 1 mg dexamethasone 2x a day for 3 days to suppress cortisol production.
- DrugCosyntropin (Group 3)
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.
- Combination ProductPET/CT Scan with FNP-59
FNP-59, a radiotracer, is administered for PET/CT scans.
Locations (2)
- University of MichiganAnn Arbor, Michigan
- BAMF Health, Inc.Grand Rapids, Michigan