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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)

RecruitingEARLY Phase 1Ages 18 Years - anyAllBenjamin Viglianti
NCT04546126 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Dexamethasone (Group 2)
  • Cosyntropin (Group 3)
  • PET/CT Scan with FNP-59
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Where

2 sites
University of Michigan
Ann Arbor, United States
BAMF Health, Inc.
Grand Rapids, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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