Cholesterol, Hypertension, Radiotracer
Conditions
Brief 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.
Detailed 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 / sensitivity / specificity without concern of thyroid exposure.
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.
Sponsors
Benjamin Viglianti
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 pathology Inclusion Criteria (Group 4): * Abnormal adrenal cortical hormone secretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in [18F]FNP-59 chemistry uptake as measured by the standardized uptake value (SUV) based gland segmentation | Day 0, Day 4 | SUV will be reported. Both maximal and average SUVs will be calculated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PET/CT image uptake score as measured by investigator visual assessment for each volume of interest (VOI) | Day 4 | Investigator scoring system (no increased uptake = 0, mild uptake = 1, moderate uptake = 2, high uptake = 3, relative to background. Higher scores indicate increased uptake. |
Countries
United States
Contacts
Primary ContactJim Pool
Outcome results
None listed