Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)
Who is this study for? Patients with Hypertension
What treatments are being studied? PET/CT Scan with FNP-59
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Combination product
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• Participants without any known adrenal pathology as normal controls for undergoing endocrine manipulation
• Abnormal adrenal cortical hormone secretion
Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
BAMF Health, Inc.
COMPLETED
Grand Rapids
Contact Information
Primary
Jim Pool
jampool@umich.edu
734-615-7391
Time Frame
Start Date: 2021-11-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 24
Treatments
Experimental: Dexamethasone (Group 2)
Participants will undergo an FNP-59 scan on day 0 in the am. Participants will then take~1 mg dexamethasone 2x a day for 3 days to suppress cortisol production. Participants will then have a second FNP-59 scan on day 4 in the am.
Experimental: Cosyntropin (Group 3)
Participants will undergo an FNP-59 scan on day 0 in the am. On day 4 the participant will arrive for imaging. 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.
Experimental: Adrenal pathology (Group 4)
Whole-body PET/CT scans will be done on 4 patients at 1 hr and the other 4 patients at 6 hours. All the patients will have a whole-body PET/CT scan at 3 hours.
Authors
Ben Viglianti
Related Therapeutic Areas
Sponsors
Leads: Benjamin Viglianti