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NCT04532489RecruitingEarly phase 1

Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)

Source: ClinicalTrials.gov · Last updated 5 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Early phase 1
Study type
Interventional
Enrollment
6 (estimated)
First submitted
27 Aug 2020
Start date
18 Jan 2021
Primary completion date
31 Dec 2026
Lead sponsor
Benjamin Viglianti
NCT number
NCT04532489

What you commit to

  • Study type: Interventional · Early phase 1
  • Planned participants: 6
  • From 18 Jan 2021 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other

  • 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
  • Known adrenal pathology

Who the study is looking for

  • Participants without any known adrenal pathology as normal controls for radiation dosimetry purposes

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Michigan
Coordinator of this site? Confirm its status
Ann ArborUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.