Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)
Overview
- Phase
- Early Phase 1
- Intervention
- Dexamethasone (Group 2)
- Conditions
- Radiotracer
- Sponsor
- Benjamin Viglianti
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Change in [18F]FNP-59 chemistry uptake as measured by the standardized uptake value (SUV) based gland segmentation
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
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.
Investigators
Benjamin Viglianti
Assistant Professor of Radiology
University of Michigan
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Dexamethasone (Group 2)
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.
Intervention: PET/CT Scan with FNP-59
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.
Intervention: Cosyntropin (Group 3)
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.
Intervention: PET/CT Scan with FNP-59
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.
Intervention: PET/CT Scan with FNP-59
Outcomes
Primary Outcomes
Change in [18F]FNP-59 chemistry uptake as measured by the standardized uptake value (SUV) based gland segmentation
Time Frame: Day 0, Day 4
SUV will be reported. Both maximal and average SUVs will be calculated
Secondary Outcomes
- PET/CT image uptake score as measured by investigator visual assessment for each volume of interest (VOI)(Day 4)