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

Last updated: November 20, 2024
Sponsor: Benjamin Viglianti
Overall Status: Active - Recruiting

Phase

1

Condition

Stress

Circulation Disorders

Vascular Diseases

Treatment

FNP-59

Clinical Study ID

NCT04532489
HUM00179097a
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants without any known adrenal pathology as normal controls for radiationdosimetry purposes

Exclusion

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)/ AngiotensinII receptor blockers (ARBs), or supplements that are hormone analogues.

  • Known adrenal pathology

Study Design

Total Participants: 6
Treatment Group(s): 1
Primary Treatment: FNP-59
Phase: 1
Study Start date:
January 18, 2021
Estimated Completion Date:
December 31, 2025

Study Description

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

Connect with a study center

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

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