Imaging cholesterol trafficking in the adrenal gland using a new radiotracer
Official title: Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)
Run by University of Michigan · NCT04546126 · Data updated 2026-11-12
This study is testing a new imaging tool to see if it can help get clearer pictures of the adrenal gland in both healthy people and those with adrenal problems.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | University of Michigan Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Ann Arbor, Michigan and 1 other locations) |
| Status | Recruiting |
| Started | November 1, 2021 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | December 5, 2025 |
| Trial ID | NCT04546126 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include healthy individuals without known adrenal pathology and those with abnormal adrenal cortical hormone secretion.
✕Probably not a fit
Patients with known adrenal pathology who are not part of the study group may 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 study evaluates the use of a fluorine-18 analogue of NP-59 ([18F]FNP-59) to improve PET imaging of the adrenal gland. Participants include healthy individuals undergoing hormone manipulation and those with known adrenal pathology. The study aims to assess the feasibility and effectiveness of this radiotracer in providing better imaging characteristics, including improved localization and sensitivity. All participants will undergo PET/CT scans after receiving the radiotracer.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of adrenal gland imaging, leading to better diagnosis and management of adrenal disorders.
How similar studies have gone: Other studies using similar imaging techniques have shown promise, but this specific approach with [18F]FNP-59 is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria (Groups 2 \& 3): * Participants without any known adrenal pathology as normal controls for undergoing endocrine manipulation Exclusion Criteria (Groups 2 \& 3): * 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 Inclusion Criteria (Group 4): * Abnormal adrenal cortical hormone secretion Exclusion Criteria (Group 4): * Pregnant
Where it's running
-
University of Michigan
Ann Arbor, Michigan, United States Recruiting -
BAMF Health, Inc.
Grand Rapids, Michigan, United States Completed
Study contacts
- Principal investigator: Benjamin L Viglianti, M.D, Ph.D. — University of Michigan
- Study coordinator: Jim Pool
- Email: jampool@umich.edu
- Phone: 734-615-7391
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.