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NCT04546126EARLY_PHASE1RecruitingAccepts Healthy Volunteers

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

Benjamin Viglianti

Start Date

11/1/2021

Completion Date

12/1/2026

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria (Groups 2 \& 3): * Participants without any known adrenal pathology as normal controls for undergoing endocrine manipulation Exclusion Criteria (Groups 2 \& 3): * 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 Inclusion Criteria (Group 4): * Abnormal adrenal cortical hormone secretion Exclusion Criteria (Group 4): * Pregnant

Interventions

DRUG

Dexamethasone (Group 2)

DRUG

Cosyntropin (Group 3)

COMBINATION_PRODUCT

PET/CT Scan with FNP-59

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Conditions

RadiotracerHypertensionCholesterol

Locations

University of Michigan

Ann Arbor, Michigan 48109

United States

BAMF Health, Inc.

Grand Rapids, Michigan 49503

United States