Study to enroll up to 90 individuals, those with an alcohol use disorder (AUD) (up to n=60) and non-dependent healthy volunteers (HV) (up to n=30). PET/CT imaging will be used to evaluate brain and whole-body inflammation using the investigational radiotracer \[18F\]NOS. All participants will have one \[18F\]NOS positron emission tomography/ computed tomography (PET/CT) scan performed.
The Investigators plan to enroll up to 90 individuals in this study, which will enroll individuals with an alcohol use disorder (AUD) (up to n=60) and non-dependent healthy volunteers (HV) (up to n=30). PET/CT imaging will be used to evaluate brain and whole-body inflammation using the investigational radiotracer \[18F\]NOS. All participants will have one \[18F\]NOS positron emission tomography/computed tomography (PET/CT) scan performed, unless this has been performed as part of another study. AUD participants enrolled in a companion treatment study #851593 "A Randomized, Double-blind Placebo-Controlled Study of Ibudilast for Treating Alcohol Use Disorder" will be asked to undergo a second \[18F\]NOS PET scan after the initiation of the study treatment. For each PET/CT scan, patients will undergo approximately 60 minutes of dynamic scanning starting at the time of injection of \[18F\]NOS. PET/CT imaging sessions will include an injection of ≤ 6.5 mCi (approximate range for most studies is anticipated to be 3.5-6.5 mCi) of \[18F\]NOS. Data will be collected to evaluate uptake of \[18F\]NOS in the brain and other organs (e.g., lungs, heart, and liver), and measurements will be compared between groups. Each participant will undergo a 90 minute brain MRI to measure brain inflammatory markers using GluCEST and spectroscopic imaging, unless this has been performed as part of another study and deemed acceptable by an investigator. On the PET day, a blood sample will be collected to measure established peripheral inflammatory biomarkers to be correlated with \[18F\]NOS uptake. AUD participants who are enrolled in the companion treatment study will be asked to undergo a second brain MRI, PET/CT scan, and blood draw for inflammatory markers after the initiation of treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
4
\[18F\]-6-(2-fluoro-propyl)-4-methylpyridin-2-amine, also known as \[18F\]NOS, is a positron emitting radiopharmaceutical that has been studied in animals and humans which permits the visualization and measurement by positron emission tomography (PET/CT) imaging of in vivo iNOS expression as a marker of inflammation.
University of Pennsylvania
Philadelphia, Pennsylvania, United States
[18F]NOS uptake (distribution volume) in the brain and other organs in body
The primary outcome measure to be analyzed is a comparisons of AUD subjects and healthy control subjects in the amount of \[18F\]NOS uptake (distribution volume) in brain and heart.
Time frame: 2 hours
Amount of c-reactive protein (mg/dl) in blood
The secondary outcome measure is the comparison of AUD subjects and healthy control subjects in the amount of c-reactive protein in mg/dl, and its association with \[18F\]NOS uptake (distribution volume) in brain and other organs in body.
Time frame: 1 hour
Amount of magnetic resonance spectroscopy Glutamate levels (in mM) in the brain
The third outcome measure to be analyzed is the comparison of AUD subjects and healthy control subjects in brain Glutamate levels (in mM), and its association with \[18F\]NOS uptake (distribution volume) in brain.
Time frame: 1 hour
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.