Tests a radioactive cholesterol tracer for imaging adrenal glands in healthy adults
Tests the radioactive tracer [18F]FNP-59 to image adrenal glands in healthy adults.
Key facts
- Who runs it
- Benjamin Viglianti
- Where
- Ann Arbor, United StatesSee the site
- Trial code
- Registry title
- Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)
- Status
- Recruiting
- Phase
- Early phase 1
- People taking part
- 6 people, planned
- Started
- 18 Jan 2021
- Expected to end
- Dec 2026
- Type of study
- Interventional
- Treatments tested
- FNP-59
- Record updated
- 5 December 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with no known adrenal gland disease. They serve as normal controls for a first study of a PET imaging tracer of the adrenal gland.
- Age
- 18 years or older
- Sex
- Men and women
- Disease stage
- No known adrenal gland disease
- Earlier treatment
- Cannot currently use steroids, birth control pills, spironolactone, estrogen, androgen, progesterone, ACE inhibitors or ARBs, or hormone-like supplements.
Main reasons for not taking part
- Pregnancy
- Known adrenal gland disease
- Unable to have imaging
- Body weight above 400 lbs (181 Kg)
- Prisoners, and people unable to give their own consent
This trial only enrols healthy participants. The registry sentence this rests on: Participants without any known adrenal pathology as normal controls for radiation dosimetry purposes
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- Participants without any known adrenal pathology as normal controls for radiation dosimetry purposes
Who cannot take part
- 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
- 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
- Known adrenal pathology
Where in United States
- University of MichiganAnn Arbor, United StatesContact: James PoolTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Group 1Other group
These subjects, 6 planned (3 male, 3 female), will be to obtain normal tissue distribution of \[18F\]NP-59 and confirm calculated radiation dosimetry and optimal uptake time.
Treatment: FNP-59
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)
- Plain-language title
- Tests a radioactive cholesterol tracer for imaging adrenal glands in healthy adultsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 5 December 2025