Clinical trials›Radiotracer›Lifestyle›Trial details
OpenLong-term Hope (5+ yrs)Treatment Study

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

For Condition: RadiotracerFor Condition: HypertensionFor Condition: Cholesterol

ID: NCT04532489

Horizon Patient Guidance Summary

Our intelligence engine has synthesized this trial record to answer your most important questions in clear, simple terms:

How it’s taken
Diet & Lifestyle / Therapy Care
Expected Availability Horizon
Long-term Hope (5+ yrs away)
StageEarly Clinical Stage: Focuses strictly on testing basic safety, toxicity, and dosage in a small group (10–50 people). Represents early-stage scientific hope.
EligibleHealthy volunteers welcome — you do not need to be diagnosed with the condition to participate.
About This Clinical Trial

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.

Read Full Scientific Objectives & Methods

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

Study Timeline & Quick Facts
Trial Status
Open — Looking for Participants
Total Target Enrollment
6 patients (Estimated)
Study Start Date
2021-01-18
Est. Primary Completion
2026-12
Tested Drugs & Treatment Groups
DRUGFNP-59

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

Treatment Arms Description

OTHERGroup 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.

Can I Join This Study?
Suitable For
Everyone welcome
Ages Welcome
18 Years and older
Full Criteria Checklist
Who Can Join
  • Participants without any known adrenal pathology as normal controls for radiation dosimetry purposes
Who Cannot Join
  • 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
What is this Study Measuring?

Primary Outcome Measures

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

    SUV will be reported. Both maximal and average SUVs will be calculated

Where to Participate

This trial is recruiting at 1 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:

Show All 1 Facilities & Contact Sites
University of Michigan
Ann Arbor, Michigan, United States
Status: Open
Trial Design & Scientific Setup
Allocation
na
Intervention Model
single group
Primary Purpose
health services research
Masking
none
Sponsoring Teams & Contacts
Lead Sponsoring Institution
Benjamin Viglianti
Primary Research Contact
Jim Pool
Tel: 734-615-7391
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View Official Medical/Scientific Title

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