RecruitingEarly Phase 1NCT04532489
Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)
Sponsor
Benjamin Viglianti
Enrollment
6 participants
Start Date
Jan 18, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
This exploratory, first-in-man, phase 0 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 in healthy normal subjects. The researchers believe that \[18F\]FNP-59 would greatly improve the imaging characteristics, by providing a PET imaging cholesterol analogue with significantly improved radiation dosimetry.
Eligibility
Min Age: 18 Years
Inclusion Criteria1
- Participants without any known adrenal pathology as normal controls for radiation dosimetry purposes
Exclusion Criteria7
- 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
Interventions
DRUGFNP-59
FNP-59, a radiotracer, is administered for PET/CT scans.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04532489
Related Trials
BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
NCT0605963898 locations
EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease
NCT070644731153 locations
OPtimizing Technology to Improve Medication Adherence and BP Control (OPTIMA-BP)
NCT052937561 location
Coaching and Navigation by Community Health Workers (CHWs) Through Telehealth for High-risk Hypertension
NCT074614154 locations
SGLT2i Improve Left Atrial Function in Patients With Paroxysmal Atrial Fibrillation, Hypertension and Abnormal Glucose Metabolism
NCT074820201 location