Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexamethasone (Group 2), Cosyntropin (Group 3), PET/CT Scan with FNP-59.
- Who it may be relevant to
- Registry conditions: Radiotracer, Hypertension, Cholesterol. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Dexamethasone (Group 2)
Participants will take 1 mg dexamethasone 2x a day for 3 days to suppress cortisol production. - Drug Cosyntropin (Group 3)
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. - Combination product PET/CT Scan with FNP-59
FNP-59, a radiotracer, is administered for PET/CT scans.
Primary outcome measures
- Change in [18F]FNP-59 chemistry uptake as measured by the standardized uptake value (SUV) based gland segmentation [Time frame: Day 0, Day 4]
Secondary outcome measures (1)
- PET/CT image uptake score as measured by investigator visual assessment for each volume of interest (VOI) [Time frame: Day 4]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 2 centers
- University of Michigan — Ann Arbor
- BAMF Health, Inc. — Grand Rapids
Identifiers
NCT: NCT04546126 · HUM00179097b