Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)
Recruiting · NCT04546126 · Interventional (participants receive a specific treatment) · Lead sponsor: Benjamin Viglianti
View the official record on ClinicalTrials.gov →Interventions studied
Cosyntropin (Group 3)Dexamethasone (Group 2)PET/CT Scan with FNP-59
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed across 1 US state.
- University of Michigan - Ann Arbor, Michigan, United States
- BAMF Health, Inc. - Grand Rapids, Michigan, United States