Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04546126

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Radiotracer Cardiovascular Diseases Cholesterol Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Michigan, Ann Arbor, Michigan, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone (Group 2)

Drug

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

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.

PET/CT Scan with FNP-59

Combination Product

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

Primary outcomes

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

    Time frame: Day 0, Day 4

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

Secondary outcomes

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

    Time frame: Day 4

    Investigator scoring system (no increased uptake = 0, mild uptake = 1, moderate uptake = 2, high uptake = 3, relative to background. Higher scores indicate increased uptake.

Study contacts

Contact information is provided by the study sponsor or research team.

Jim Pool

CONTACT

[email protected]

734-615-7391

Sponsors and collaborators

Lead sponsor

Benjamin Viglianti

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2020
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.