Recruiting
Early Phase 1

[18F]FNP-59

Sponsor:

Benjamin Viglianti

Code:

NCT04546126

Conditions

Radiotracer

Hypertension

Cholesterol

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Dexamethasone (Group 2)

Cosyntropin (Group 3)

PET/CT Scan with FNP-59

Study Details

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.

Conditions

Radiotracer

Hypertension

Cholesterol

Study ID

NCT04546126

Start date

Nov 1, 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 (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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Dexamethasone (Group 2)

Participants will undergo an FNP-59 scan on day 0 in the am. Participants will then take

1 mg dexamethasone 2x a day for 3 days to suppress cortisol production. Participants will then have a second FNP-59 scan on day 4 in the am.

experimental: Cosyntropin (Group 3)

Participants will undergo an FNP-59 scan on day 0 in the am. On day 4 the participant will arrive for imaging. Cosyntropin, 250 micro-gm will be administered IV. Five minutes following administration FNP-59 will be given. Following uptake of FNP-59 imaging will occur.

experimental: Adrenal pathology (Group 4)

Whole-body PET/CT scans will be done on 4 patients at 1 hr and the other 4 patients at 6 hours. All the patients will have a whole-body PET/CT scan at 3 hours.

Interventions

Dexamethasone (Group 2)

Participants will take 1 mg dexamethasone 2x a day for 3 days to suppress cortisol production.

Cosyntropin (Group 3)

Cosyntropin, 250 micro-gm will be administered IV. Five minutes following administration FNP-59 will be given. Following uptake of FNP-59 imaging will occur.

PET/CT Scan with FNP-59

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

Primary outcome measure

  • Change in [18F]FNP-59 chemistry uptake as measured by the standardized uptake value (SUV) based gland segmentation [ Time Frame: Day 0, Day 4 ]

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 L 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.