About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants without any known adrenal pathology as normal controls for undergoing endocrine manipulation
Disqualifiers
Pregnancy
Unable to do imaging
Body weight greater than 400 lbs (181 Kg)
Prisoners are not eligible
Trial design
Parallel
Treatments tested in this trial
Dexamethasone (Group 2)
DrugParticipants will take 1 mg dexamethasone 2x a day for 3 days to suppress cortisol production.
Cosyntropin (Group 3)
DrugCosyntropin, 250 micro-gm will be administered IV. Five minutes following administration FNP-59 will be given. Following uptake of FNP-59 imaging will occur.
PET/CT Scan with FNP-59
Combination productFNP-59, a radiotracer, is administered for PET/CT scans.
Treatment groups
Trial outcomes
Primary outcomes
Change in [18F]FNP-59 chemistry uptake as measured by the standardized uptake value (SUV) based gland segmentation
SUV will be reported. Both maximal and average SUVs will be calculated
Secondary outcomes
PET/CT image uptake score as measured by investigator visual assessment for each volume of interest (VOI)
Investigator scoring system (no increased uptake = 0, mild uptake = 1, moderate uptake = 2, high uptake = 3, relative to background. Higher scores indicate increased uptake.
Sponsors and contacts
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Benjamin Viglianti
Lead sponsor
University of Michigan
Sponsor institution