Imaging cholesterol trafficking in the adrenal gland using a new radiotracer
Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)
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 |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Ann Arbor, Michigan and 1 other locations) |
| Trial ID | NCT04546126 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include healthy individuals without known adrenal pathology and those with abnormal adrenal cortical hormone secretion.
Not a fit: Patients with known adrenal pathology who are not part of the study group may not benefit from this study.
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 performed: Other studies using similar imaging techniques have shown promise, but this specific approach with [18F]FNP-59 is novel.
Eligibility criteria
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 this trial is running
Ann Arbor, Michigan and 1 other locations
- 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
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.