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

NCT04546126 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-12-05

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Benjamin Viglianti

    lead OTHER

Principal Investigators

  • Benjamin L Viglianti, M.D, Ph.D. · University of Michigan

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04546126 on ClinicalTrials.gov