NCT04546126 Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)
| NCT ID | NCT04546126 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Benjamin Viglianti |
| Condition | Radiotracer |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2021-11-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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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 24 participants in total. It began in 2021-11-01 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 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. Some participants are healthy normal subjects but have undergone interventions to manipulate hormones while other participants have known adrenal pathology.
Eligibility 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
Contact & Investigator
Benjamin L Viglianti, M.D, Ph.D.
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT04546126 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 NCT04546126 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 NCT04546126 currently recruiting?
Yes, NCT04546126 is actively recruiting participants. Contact the research team at jampool@umich.edu for enrollment information.
Where is the NCT04546126 trial being conducted?
This trial is being conducted at Ann Arbor, United States, Grand Rapids, United States.
Who is sponsoring the NCT04546126 clinical trial?
NCT04546126 is sponsored by Benjamin Viglianti. The principal investigator is Benjamin L Viglianti, M.D, Ph.D. at University of Michigan. The trial plans to enroll 24 participants.