Imaging Inflammation in Individuals With Alcohol Use Disorder: an [18F]NOS Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- [18F]NOS uptake (distribution volume) in the brain and other organs in body
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
AUD-Alcohol Use Disorder
60 adult men and women who have alcohol use disorder will undergo up to 2 PET/CT scans each 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.
干预措施: [18F]NOS (Drug)
HV-Healthy Volunteer
30 adult men and women between the ages of 18-65 who do not have alcohol use disorder and are a healthy volunteer will be enrolled in this study.
干预措施: [18F]NOS (Drug)
结局指标
主要结局
[18F]NOS uptake (distribution volume) in the brain and other organs in body
时间窗: 2 hours
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.
次要结局
- Amount of c-reactive protein (mg/dl) in blood(1 hour)
- Amount of magnetic resonance spectroscopy Glutamate levels (in mM) in the brain(1 hour)
