Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)
- Conditions
- HypertensionRadiotracerCholesterol
- Interventions
- Combination Product: PET/CT Scan with FNP-59
- Registration Number
- NCT04546126
- Lead Sponsor
- Benjamin Viglianti
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 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. Cosyntropin (Group 3) PET/CT Scan with FNP-59 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. Dexamethasone (Group 2) PET/CT Scan with FNP-59 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. Adrenal pathology (Group 4) PET/CT Scan with FNP-59 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. 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.
- Primary Outcome Measures
Name Time Method Change in [18F]FNP-59 chemistry uptake as measured by the standardized uptake value (SUV) based gland segmentation Day 0, Day 4 SUV will be reported. Both maximal and average SUVs will be calculated
- Secondary Outcome Measures
Name Time Method PET/CT image uptake score as measured by investigator visual assessment for each volume of interest (VOI) Day 4 Investigator scoring system (no increased uptake = 0, mild uptake = 1, moderate uptake = 2, high uptake = 3, relative to background. Higher scores indicate increased uptake.
Trial Locations
- Locations (2)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
BAMF Health, Inc.
🇺🇸Grand Rapids, Michigan, United States