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
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 6 (estimated) |
| Sponsor | University of Michigan Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Ann Arbor, Michigan) |
| Status | Recruiting |
| Started | January 18, 2021 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | December 5, 2025 |
| Trial ID | NCT04532489 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.
-
Imaging cholesterol trafficking in the adrenal gland using a new radiotracer
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.
-
Using low-dose aspirin after preeclampsia to improve recovery
This study is testing if taking low-dose aspirin for six months after having preeclampsia can help new moms recover better by improving their blood pressure and blood vessel function.
-
IMB-guided health education to boost medication taking and blood pressure control in adults with hypertension
This study tests a health-literacy program based on Information-Motivation-Behavioral Skills to help adults with hypertension who don’t take their medicines regularly to take them more consistently and better control their blood pressure.
-
Renal Nerve Stimulation to Help Blood Pressure in AF and HFpEF
This study tests whether stimulating the kidneys with a catheter can safely lower blood pressure in adults with atrial fibrillation and HFpEF who also have hypertension.
-
Hypertension: Does Education Help Patients Manage Blood Pressure Better?
This study tests whether structured patient education improves blood pressure control and self-management in adults with hypertension who speak Turkish.
-
High BMI and periodontitis in Thai adults under 60
This study tests how common high BMI and periodontitis are among Thai adults aged 18–59 and what factors are linked to them.
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.