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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Cholesterol; Radiotracer
• Intervention / Treatment: Drug: Dexamethasone (Group 2); Combination product: PET/CT Scan with FNP-59; Drug: Cosyntropin (Group 3)

Detailed Description

Groups 2 & 3 used hormone manipulation using information gathered from Group 1 which identified radiation dosimetry and optimal uptake time.

Group 4 (added to the study later) includes participants with known adrenal pathology. They will not have study associated hormone manipulation.

All groups will be given a radio-tracer and PET/CT scans.

The researchers believe that a fluorine-18 analogue of NP-59, [18F]FNP-59, would greatly improve the imaging characteristics, by providing a PET imaging cholesterol analogue with significantly improved radiation dosimetry, and improved localization / sensitivity / specificity without concern of thyroid exposure.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Jim Pool; Phone Number: 734-615-7391; Email: jampool@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: James Pool; Phone Number: 734-615-7391; Email: jampool@umich.edu
      • Principal Investigator: Benjamin L Viglianti, M.D, Ph.D.
    • Grand Rapids, Michigan, United States, 49503
      • Completed
      • BAMF Health, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Dexamethasone (Group 2); Participants will take 1 mg dexamethasone 2x a day for 3 days to suppress cortisol production.; Combination product: PET/CT Scan with FNP-59; FNP-59, a radiotracer, is administered for PET/CT scans.
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.	Combination product: PET/CT Scan with FNP-59; FNP-59, a radiotracer, is administered for PET/CT scans.; Drug: 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.
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.	Combination product: PET/CT Scan with FNP-59; FNP-59, a radiotracer, is administered for PET/CT scans.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PET/CT image uptake score as measured by investigator visual assessment for each volume of interest (VOI)	Investigator scoring system (no increased uptake = 0, mild uptake = 1, moderate uptake = 2, high uptake = 3, relative to background. Higher scores indicate increased uptake.	Day 4

Collaborators and Investigators

• Sponsor: Benjamin Viglianti
• Investigators: Principal Investigator: Benjamin L Viglianti, M.D, Ph.D., University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (Actual): September 11, 2020

Study Record Updates

• Last Update Posted (Estimated): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Hypothalamic Hormones; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Pituitary Hormones; Pituitary Hormones, Anterior; Melanocortins; Pro-Opiomelanocortin; Adrenocorticotropic Hormone; Dexamethasone; Cosyntropin
• Other Study ID Numbers: HUM00179097b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No