Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
Healthy Volunteers
NCT04532489

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

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

6

Participants Needed

1

Research Sites

306 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

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Research Team

J

Jim Pool

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

1

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