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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Benjamin Viglianti
Study ID
NCT04532489
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • FNP-59 — DRUG
    FNP-59, a radiotracer, is administered for PET/CT scans.

Study Details

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.

Key Dates

Start date
Jan 18, 2021
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Other: Group 1
    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 Measure

Uptake for [18F]FNP-59 in the adrenal glands using the standardized uptake value (SUV) based on gland segmentation [ Time Frame: Day 0 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
James Pool
[email protected]
734-615-7391
Benjamin Viglianti, M.D, Ph.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Ann Arbor, MI

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
University of Michigan· Ann Arbor, MI

Related Studies