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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBenjamin Viglianti

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants without any known adrenal pathology as normal controls for radiation dosimetry purposes

Disqualifiers

Pregnancy

Unable to do imaging

Body weight greater than 400 lbs (181 Kg)

Prisoners are not eligible

Trial design

Design model

Single group

Treatments tested in this trial

  • FNP-59

    Drug

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

Treatment groups

6 Participants
are divided into 1 treatment group
Group A: Group 1Other 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Day 0

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Benjamin Viglianti

Lead sponsor

University of Michigan

Sponsor institution