Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)
Recruiting · NCT04532489 · Interventional (participants receive a specific treatment) · Lead sponsor: Benjamin Viglianti
View the official record on ClinicalTrials.gov →Interventions studied
FNP-59
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- University of Michigan - Ann Arbor, Michigan, United States