Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)

What Was Tested

In this early phase 1 trial, researchers set out to test Cosyntropin.

Some participants are healthy normal subjects but have undergone interventions to manipulate hormones while other participants have known adrenal pathology.

It had three arms (groups): Dexamethasone (Group 2) (experimental), Cosyntropin (Group 3) (experimental) and Adrenal pathology (Group 4) (experimental).

Whole-body PET/CT scans will be done on 4 patients at 1 hr and the other 4 patients at 6 hours. All the patients will have a whole-body PET/CT scan at 3 hours.

The registry classes the interventions as combination product and drug.

More on the Plan

Groups 2 \& 3 used hormone manipulation using information gathered from Group 1 which identified radiation dosimetry and optimal uptake time.

Group 4 (added to the study later) includes participants with known adrenal pathology.

They will not have study associated hormone manipulation.

All groups will be given a radio-tracer and PET/CT scans.

Who Took Part

The registry lists 24 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Participants without any known adrenal pathology as normal controls for undergoing endocrine manipulation.

The full record lists 1 inclusion and 9 exclusion criteria; among the exclusions: unable to do imaging; body weight greater than 400 lbs (181 kg); prisoners are not eligible.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

The Cosyntropin group and the comparison group ran side by side rather than switching.

Being open-label, the Cosyntropin study did not mask who received what.

It started in 2021-11-01 with completion listed for 2026-12.

It ran at 2 sites in United States (2).

Its stated primary purpose is health services research.

What Was Measured

Researchers chose this as the main measure: Change in [18F]FNP-59 chemistry uptake as measured by the standardized uptake value (SUV) based gland segmentation (time frame: Day 0, Day 4).

It also tracked 1 secondary outcome, for example PET/CT image uptake score as measured by investigator visual assessment for each volume of interest (VOI).

What This Means in Plain Language

Put simply, this is a early phase 1, non-randomized trial of Cosyntropin in 24 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cosyntropin compound page, all human trials.