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

Early Phase 1

Recruiting

• Conditions: Cholesterol; Hypertension; Radiotracer
• Interventions: Drug: FNP-59

• Registration Number: NCT04532489
• Lead Sponsor: Benjamin Viglianti

Brief 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2020-08-27
• Study First Submitted QC: 2020-08-27
• Study First Posted: 2020-08-31
• Study Start: 2021-01-18
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 1	FNP-59	These subjects, 6 planned (3 male, 3 female), will be to obtain normal tissue distribution of \[18F\]NP-59 and confirm calculated radiation dosimetry and optimal uptake time.

Primary Outcome Measures

Name	Time	Method
Uptake for [18F]FNP-59 in the adrenal glands using the standardized uptake value (SUV) based on gland segmentation	Day 0	SUV will be reported. Both maximal and average SUVs will be calculated

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States