Imaging cholesterol trafficking in healthy individuals using a new PET tracer
Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)
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 |
| Enrollment | 6 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT04532489 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy individuals without any known adrenal pathology.
Not a fit: Patients with known adrenal pathology or those currently using certain hormonal medications will not benefit from this study.
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 performed: While this approach is novel, similar imaging techniques have shown promise in other studies, indicating potential for success.
Eligibility criteria
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 this trial is running
Ann Arbor, Michigan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.