What this study is
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's being tested
- FNP-59
Intervention · DRUG
FNP-59, a radiotracer, is administered for PET/CT scans.
Study details
- Sponsor
- Benjamin Viglianti
- Conditions
- Radiotracer · Hypertension · Cholesterol
- Enrolling
- 6 people
- Starts
- 2021-01-18
- Est. completion
- 2026-12
- Design
- Open-label, single group, Early Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- Participants without any known adrenal pathology as normal controls for radiation dosimetry purposes
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openUniversity of Michigan
Ann Arbor, Michigan, United States
- James Pool · Contact734-615-7391jampool@umich.edu
- Benjamin Viglianti, M.D, Ph.D. · Principal investigator
Recruiting
Study team
Sponsor
Benjamin Viglianti
Study ID HUM00179097a
Principal investigator
Ben Viglianti, M.D, Ph.D.
University of Michigan
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.