RecruitingEarly Phase 1NCT04546126

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


Sponsor

Benjamin Viglianti

Enrollment

24 participants

Start Date

Nov 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new PET scan imaging agent called [18F]FNP-59 that tracks cholesterol movement in the adrenal glands — both in healthy volunteers and in patients with adrenal hormone disorders — to better understand adrenal gland function. **You may be eligible if...** - For Groups 2 and 3: You are a healthy adult with no known adrenal gland disease, willing to undergo a specific hormonal manipulation followed by PET imaging - For Group 4: You have been diagnosed with an adrenal condition involving abnormal hormone secretion - You are able to provide your own consent and undergo imaging - You weigh under 400 lbs (181 kg) **You may NOT be eligible if...** - You are pregnant - You have a known adrenal problem (for healthy volunteer groups) - You use steroids, hormonal medications, or certain blood pressure drugs (ACE inhibitors/ARBs) - You are a prisoner Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDexamethasone (Group 2)

Participants will take 1 mg dexamethasone 2x a day for 3 days to suppress cortisol production.

DRUGCosyntropin (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_PRODUCTPET/CT Scan with FNP-59

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


Locations(2)

University of Michigan

Ann Arbor, Michigan, United States

BAMF Health, Inc.

Grand Rapids, Michigan, United States

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NCT04546126


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