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

Inclusion Criteria2

  • Participants without any known adrenal pathology as normal controls for undergoing endocrine manipulation
  • Abnormal adrenal cortical hormone secretion

Exclusion Criteria8

  • 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
  • Pregnant

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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