Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-25 @ 1:35 AM
NCT ID:
NCT05885594
Brief Summary:
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.
Detailed Description:
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:
NCT05885594
Study Brief:
Protocol Section:
NCT05885594