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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Benjamin Viglianti
• Treatments: Cosyntropin; Dexamethasone

Criteria

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