Back to resultsPositron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)
Primary Purpose
Radiotracer, Hypertension, Cholesterol
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
FNP-59
Sponsored by
About this trial
This is an interventional health services research trial for Radiotracer
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
Sites / Locations
- University of MichiganRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Group 1
Arm Description
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.
Outcomes
Primary Outcome Measures
Uptake for [18F]FNP-59 in the adrenal glands using the standardized uptake value (SUV) based on gland segmentation
SUV will be reported. Both maximal and average SUVs will be calculated
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04532489
Brief Title
Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)
Official Title
Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Benjamin Viglianti
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiotracer, Hypertension, Cholesterol
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Other
Arm Description
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 Type
Drug
Intervention Name(s)
FNP-59
Intervention Description
FNP-59, a radiotracer, is administered for PET/CT scans.
Primary Outcome Measure Information:
Title
Uptake for [18F]FNP-59 in the adrenal glands using the standardized uptake value (SUV) based on gland segmentation
Description
SUV will be reported. Both maximal and average SUVs will be calculated
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jim Pool
Phone
734-615-7391
Email
jampool@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Viglianti, M.D, Ph.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Pool
Phone
734-615-7391
Email
jampool@umich.edu
First Name & Middle Initial & Last Name & Degree
Benjamin Viglianti, M.D, Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)
We'll reach out to this number within 24 hrs