Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
Healthy Volunteers
NCT04546126

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

Led by Benjamin Viglianti · Updated on 2025-12-05

24

Participants Needed

2

Research Sites

265 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants without any known adrenal pathology for Groups 2 and 3 as normal controls undergoing hormone manipulation
  • Abnormal adrenal cortical hormone secretion for Group 4
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Unable to do imaging
  • Body weight greater than 400 lbs (181 Kg)
  • Prisoners are not eligible
  • Subjects unable to provide own consent
  • Current use of steroids, oral contraceptives, spironolactone, estrogen, androgen, progesterone, ACE inhibitors, ARBs, or hormone analogue supplements
  • Known adrenal pathology for Groups 2 and 3
  • Pregnant for Group 4

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

2

BAMF Health, Inc.

Grand Rapids, Michigan, United States, 49503

Completed

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Research Team

J

Jim Pool

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

3

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