NCT04546126

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Benjamin Viglianti · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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. The researchers believe that a fluorine-18 analogue of NP-59, \[18F\]FNP-59, would greatly improve the imaging characteristics, by providing a PET imaging cholesterol analogue with significantly improved radiation dosimetry, and improved localization / sensitivity / specificity without concern of thyroid exposure.

Conditions

• Radiotracer
• Hypertension
• Cholesterol

Interventions

Type	Name	Description
DRUG	Dexamethasone (Group 2)	Participants will take 1 mg dexamethasone 2x a day for 3 days to suppress cortisol production.
DRUG	Cosyntropin (Group 3)	Cosyntropin, 250 micro-gm will be administered IV. Five minutes following administration FNP-59 will be given. Following uptake of FNP-59 imaging will occur.
COMBINATION_PRODUCT	PET/CT Scan with FNP-59	FNP-59, a radiotracer, is administered for PET/CT scans.

Timeline

• Start date: 2021-11-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2020-09-11
• Last updated: 2025-12-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study