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

Last updated: November 27, 2025
Sponsor: Benjamin Viglianti
Overall Status: Active - Recruiting

Phase

1

Condition

Stress

Circulation Disorders

Williams Syndrome

Treatment

Cosyntropin (Group 3)

PET/CT Scan with FNP-59

Dexamethasone (Group 2)

Clinical Study ID

NCT04546126
HUM00179097b
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Total Participants: 24
Treatment Group(s): 3
Primary Treatment: Cosyntropin (Group 3)
Phase: 1
Study Start date:
November 01, 2021
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • BAMF Health, Inc.

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Active - Recruiting

  • BAMF Health, Inc.

    Grand Rapids 4994358, Michigan 5001836 49503
    United States

    Completed

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