RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-01-18
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04532489

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants without any known adrenal pathology as normal controls for radiation dosimetry purposes
  1. * Pregnancy
  2. * Unable to do imaging
  3. * Body weight greater than 400 lbs (181 Kg)
  4. * Prisoners are not eligible
  5. * Subjects unable to provide own consent are not eligible
  6. * 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.
  7. * Known adrenal pathology

Contacts and Locations

Study Contact

Jim Pool
CONTACT
734-615-7391
jampool@umich.edu

Principal Investigator

Ben Viglianti, M.D, Ph.D.
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: Benjamin Viglianti

  • Ben Viglianti, M.D, Ph.D., PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-18
Study Completion Date2025-12

Study Record Updates

Study Start Date2021-01-18
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Radiotracer
  • Hypertension
  • Cholesterol