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NCT Number: NCT04532489

Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)

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.

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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, 48109, United States

Location status: Recruiting

Location contact

Benjamin Viglianti, M.D, Ph.D.

PRINCIPAL_INVESTIGATOR

James Pool

CONTACT

[email protected]

734-615-7391

About this study

Following the results of radiation dosimetry from this study then next steps will be taken for groups 2 & 3 using hormone manipulation.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

FNP-59

Drug

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

Primary outcomes

  1. Uptake for [18F]FNP-59 in the adrenal glands using the standardized uptake value (SUV) based on gland segmentation

    Time frame: Day 0

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

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
Aug 31, 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.

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