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Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)
RecruitingEarly phase 1Healthy volunteers welcome
Who can join
Ages 18 and older · All sexes · Healthy volunteers welcome
Full eligibility criteria
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
About the study
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.
What is being tested
- FNP-59 (drug)
Sponsor: Benjamin Viglianti · Participants: 6 · Started: Jan 18, 2021
Contact the study team
- Jim Pool · Phone: 734-615-7391
Official record on ClinicalTrials.gov — NCT04532489
Locations in the U.S.
| Michigan | University of Michigan, Ann Arbor |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.