Clinical trial Recruiting at 1 site Early Phase 1 Interventional Ages 18 and up

Imaging cholesterol trafficking in healthy individuals using a new PET tracer

Official title: Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)

Run by University of Michigan · NCT04532489 · Data updated 2026-11-12

This study is testing a new imaging method to see how cholesterol moves in the body by using a special tracer in healthy people.

Quick facts

PhaseEarly Phase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment6 (estimated)
SponsorUniversity of Michigan
Academic / other
Drugs / interventionsradiation
Locations1 site (Ann Arbor, Michigan)
StatusRecruiting
StartedJanuary 18, 2021
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedDecember 5, 2025
Trial IDNCT04532489 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are healthy individuals without any known adrenal pathology.

Probably not a fit

Patients with known adrenal pathology or those currently using certain hormonal medications will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This exploratory phase 0 study aims to evaluate the feasibility of using a sub-therapeutic dose of a fluorine-18 analogue of NP-59 ([18F]FNP-59) for imaging the adrenal gland in healthy subjects. The study focuses on assessing the imaging characteristics of [18F]FNP-59, which is expected to provide improved radiation dosimetry compared to existing methods. Following the initial results, further studies will be conducted involving hormone manipulation in subsequent groups. The goal is to enhance the understanding of cholesterol trafficking in the body.

Why it matters

Potential benefit: If successful, this study could lead to improved imaging techniques for assessing adrenal gland function and cholesterol metabolism.

How similar studies have gone: While this approach is novel, similar imaging techniques have shown promise in other studies, indicating potential for success.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • University of Michigan
    Ann Arbor, Michigan, United States
    Recruiting

Study contacts

  • Principal investigator: Ben Viglianti, M.D, Ph.D. — University of Michigan
  • Study coordinator: Jim Pool
  • Email: jampool@umich.edu
  • Phone: 734-615-7391

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.