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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Benjamin Viglianti
Study ID
NCT04546126
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Dexamethasone (Group 2) — DRUG
    Participants will take 1 mg dexamethasone 2x a day for 3 days to suppress cortisol production.
  • Cosyntropin (Group 3) — DRUG
    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.
  • PET/CT Scan with FNP-59 — COMBINATION_PRODUCT
    FNP-59, a radiotracer, is administered for PET/CT scans.

Study Details

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.

Key Dates

Start date
Nov 1, 2021
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • 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.

Primary Outcome Measure

Change in [18F]FNP-59 chemistry uptake as measured by the standardized uptake value (SUV) based gland segmentation [ Time Frame: Day 0, Day 4 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
James Pool
[email protected]
734-615-7391
Benjamin L Viglianti, M.D, Ph.D. (PRINCIPAL_INVESTIGATOR)
BAMF Health, Inc.Grand RapidsMichigan49503-

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By condition
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By specialty
CardiologyHeart disease
By research site
University of Michigan· Ann Arbor, MIBAMF Health, Inc.· Grand Rapids, MI

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