Trial · Interventional
RecruitingEarly phase 1Registry dataPositron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)
Overview
- Status
- Recruiting
- Phase
- Early phase 1
- Enrollment
- 24 participants (estimated)
- Sponsor
- Benjamin Viglianti · Other
- Design
- Not randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- 1 Nov 2021
- Primary completion
- Dec 2026 (estimated)
- Completion
- Dec 2026 (estimated)
- First posted
- 11 Sept 2020
- Last update posted
- 5 Dec 2025
- Conditions
- Radiotracer · Hypertension · Cholesterol
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph Early 1
Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)
NCT045461261 Nov 2021 to est. Dec 2026
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Dexamethasone (Group 2)Drug
- Cosyntropin (Group 3)Drug
- PET/CT Scan with FNP-59Combination product
Arms3
Experimental
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.
Experimental
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.
Experimental
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.
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in [18F]FNP-59 chemistry uptake as measured by the standardized uptake value (SUV) based gland segmentation
Time frame · Day 0, Day 4
Registry description
SUV will be reported. Both maximal and average SUVs will be calculated
Secondary outcomes(1)
PET/CT image uptake score as measured by investigator visual assessment for each volume of interest (VOI)
Time frame · Day 4
Registry 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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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