Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)

NCT04546126 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: HUM00179097b
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Change in [18F]FNP-59 chemistry uptake as measured by the standardized uptake value (SUV) based gland segmentation

  SUV will be reported. Both maximal and average SUVs will be calculated

  Day 0, Day 4

Secondary Outcomes (1)

• PET/CT image uptake score as measured by investigator visual assessment for each volume of interest (VOI)

  Day 4

Study Arms (3)

Dexamethasone (Group 2)

EXPERIMENTAL

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.

Drug: Dexamethasone (Group 2); Combination Product: PET/CT Scan with FNP-59

Cosyntropin (Group 3)

EXPERIMENTAL

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.

Drug: Cosyntropin (Group 3); Combination Product: PET/CT Scan with FNP-59

Adrenal pathology (Group 4)

EXPERIMENTAL

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.

Combination Product: PET/CT Scan with FNP-59

Interventions

Dexamethasone (Group 2) DRUG

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

Dexamethasone (Group 2)

Cosyntropin (Group 3) DRUG

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.

Cosyntropin (Group 3)

PET/CT Scan with FNP-59 COMBINATION_PRODUCT

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

Adrenal pathology (Group 4); Cosyntropin (Group 3); Dexamethasone (Group 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants without any known adrenal pathology as normal controls for undergoing endocrine manipulation

You may not qualify if:

• 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
• Abnormal adrenal cortical hormone secretion
• Pregnant

Sponsors & Collaborators

• Benjamin Viglianti: lead

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

BAMF Health, Inc.

Grand Rapids, Michigan, 49503, United States

COMPLETED

MeSH Terms

Conditions

Hypertension

Interventions

Dexamethasone; Cosyntropin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Adrenocorticotropic Hormone; Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Benjamin L Viglianti, M.D, Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jim Pool

CONTACT

734-615-7391; jampool@umich.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Radiology

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 11, 2020
• Study Start: November 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)