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NCT04532489 Clinical Trial

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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04532489
Other study ID # HUM00179097a
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date January 18, 2021
Est. completion date December 2024

Study information
Verified date November 2023
Source University of Michigan
Contact Jim Pool
Phone 734-615-7391
Email jampool@umich.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 6
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participants without any known adrenal pathology as normal controls for radiation dosimetry purposes 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)/ Angiotensin II receptor blockers (ARBs), or supplements that are hormone analogues. - Known adrenal pathology

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• FNP-59
FNP-59, a radiotracer, is administered for PET/CT scans.

Locations
Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (1)
Lead Sponsor Collaborator
Benjamin Viglianti

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Uptake for [18F]FNP-59 in the adrenal glands using the standardized uptake value (SUV) based on gland segmentation SUV will be reported. Both maximal and average SUVs will be calculated Day 0
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