NCT04532489 Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)
| NCT ID | NCT04532489 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Benjamin Viglianti |
| Condition | Radiotracer |
| Study Type | INTERVENTIONAL |
| Enrollment | 6 participants |
| Start Date | 2021-01-18 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 6 participants in total. It began in 2021-01-18 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This exploratory, first-in-man, phase 0 study will evaluate the feasibility of using a sub-therapeutic dose of a fluorine-18 analogue of NP-59 (\[18F\]FNP-59) to image the adrenal gland in healthy normal subjects. The researchers believe that \[18F\]FNP-59 would greatly improve the imaging characteristics, by providing a PET imaging cholesterol analogue with significantly improved radiation dosimetry.
Eligibility 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
Contact & Investigator
Ben Viglianti, M.D, Ph.D.
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT04532489 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Radiotracer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04532489 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04532489 currently recruiting?
Yes, NCT04532489 is actively recruiting participants. Contact the research team at jampool@umich.edu for enrollment information.
Where is the NCT04532489 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT04532489 clinical trial?
NCT04532489 is sponsored by Benjamin Viglianti. The principal investigator is Ben Viglianti, M.D, Ph.D. at University of Michigan. The trial plans to enroll 6 participants.