Back to resultsPositron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)
Primary Purpose
Radiotracer, Hypertension, Cholesterol
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone (Group 2)
Cosyntropin (Group 3)
PET/CT Scan with FNP-59
Sponsored by
About this trial
This is an interventional health services research trial for Radiotracer
Eligibility 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
Sites / Locations
- University of MichiganRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Dexamethasone (Group 2)
Cosyntropin (Group 3)
Adrenal pathology (Group 4)
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Change in [18F]FNP-59 chemistry uptake as measured by the standardized uptake value (SUV) based gland segmentation
SUV will be reported. Both maximal and average SUVs will be calculated
Secondary Outcome Measures
PET/CT image uptake score as measured by investigator visual assessment for each volume of interest (VOI)
Investigator scoring system (no increased uptake = 0, mild uptake = 1, moderate uptake = 2, high uptake = 3, relative to background. Higher scores indicate increased uptake.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04546126
Brief Title
Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)
Official Title
Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 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 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.
Detailed Description
Groups 2 & 3 used hormone manipulation using information gathered from Group 1 which identified radiation dosimetry and optimal uptake time.
Group 4 (added to the study later) includes participants with known adrenal pathology. They will not have study associated hormone manipulation.
All groups will be given a radio-tracer and PET/CT scans.
The researchers believe that a fluorine-18 analogue of NP-59, [18F]FNP-59, would greatly improve the imaging characteristics, by providing a PET imaging cholesterol analogue with significantly improved radiation dosimetry, and improved localization / sensitivity / specificity without concern of thyroid exposure.
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
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone (Group 2)
Arm Type
Experimental
Arm Description
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.
Arm Title
Cosyntropin (Group 3)
Arm Type
Experimental
Arm Description
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.
Arm Title
Adrenal pathology (Group 4)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone (Group 2)
Intervention Description
Participants will take 1 mg dexamethasone 2x a day for 3 days to suppress cortisol production.
Intervention Type
Drug
Intervention Name(s)
Cosyntropin (Group 3)
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
PET/CT Scan with FNP-59
Intervention Description
FNP-59, a radiotracer, is administered for PET/CT scans.
Primary Outcome Measure Information:
Title
Change in [18F]FNP-59 chemistry uptake as measured by the standardized uptake value (SUV) based gland segmentation
Description
SUV will be reported. Both maximal and average SUVs will be calculated
Time Frame
Day 0, Day 4
Secondary Outcome Measure Information:
Title
PET/CT image uptake score as measured by investigator visual assessment for each volume of interest (VOI)
Description
Investigator scoring system (no increased uptake = 0, mild uptake = 1, moderate uptake = 2, high uptake = 3, relative to background. Higher scores indicate increased uptake.
Time Frame
Day 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
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
Benjamin L 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 L 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 (Groups 2, 3 & 4)
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