Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)
Overview
- Phase
- Early Phase 1
- Intervention
- FNP-59
- Conditions
- Radiotracer
- Sponsor
- Benjamin Viglianti
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Uptake for [18F]FNP-59 in the adrenal glands using the standardized uptake value (SUV) based on gland segmentation
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
This exploratory, first-in-man, phase 0 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 in healthy normal subjects. The researchers believe that [18F]FNP-59 would greatly improve the imaging characteristics, by providing a PET imaging cholesterol analogue with significantly improved radiation dosimetry.
Detailed Description
Following the results of radiation dosimetry from this study then next steps will be taken for groups 2 \& 3 using hormone manipulation.
Investigators
Benjamin Viglianti
Assistant Professor of Radiology
University of Michigan
Eligibility Criteria
Inclusion Criteria
- •Participants without any known adrenal pathology as normal controls for radiation dosimetry purposes
Exclusion Criteria
- •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
Arms & Interventions
Group 1
These subjects, 6 planned (3 male, 3 female), will be to obtain normal tissue distribution of \[18F\]NP-59 and confirm calculated radiation dosimetry and optimal uptake time.
Intervention: FNP-59
Outcomes
Primary Outcomes
Uptake for [18F]FNP-59 in the adrenal glands using the standardized uptake value (SUV) based on gland segmentation
Time Frame: Day 0
SUV will be reported. Both maximal and average SUVs will be calculated