Recruiting
Early Phase 1

[18F]FNP-59

Sponsor:

Benjamin Viglianti

Code:

NCT04532489

Conditions

Radiotracer

Hypertension

Cholesterol

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

FNP-59

Study Details

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.

Conditions

Radiotracer

Hypertension

Cholesterol

Study ID

NCT04532489

Start date

Jan 18, 2021

Status verified date

Nov, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

6 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: Group 1

These subjects, 6 planned (3 male, 3 female), will be to obtain normal tissue distribution of \[18F\]NP-59 and confirm calculated radiation dosimetry and optimal uptake time.

Interventions

FNP-59

FNP-59, a radiotracer, is administered for PET/CT scans.

Primary outcome measure

  • Uptake for [18F]FNP-59 in the adrenal glands using the standardized uptake value (SUV) based on gland segmentation [ Time Frame: Day 0 ]

Central Contacts and Locations

Central contacts

Jim Pool

734-615-7391jampool@umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

James Pool

734-615-7391jampool@umich.edu

Principal Investigator:

Benjamin Viglianti, M.D, Ph.D.

More Information

Sponsor

Benjamin Viglianti

Last update posted

Dec 5, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Benjamin Viglianti on 2025-12-05.