Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Neuroinflammation will be measured in healthy volunteers and compared to neuroinflammation in individuals with pain and fatigue, as measured with [F-18]DPA-714-PET/MRI.
研究概览
简要总结
The primary objective of this study is to measure the concentration and the regional brain distribution of activated brain microglia/macrophages using the PET radiopharmaceutical [F-18]DPA-714 in individuals with chronic pain and fatigue suspected to be associated with neuroinflammation. The PET tracer [F-18]DPA-714 binds to the 18 kDa translocator protein (TSPO, also known as the peripheral benzodiazepine receptor) in the mitochondria of activated microglia/macrophages and provides a non-invasive measure of neuroinflammation. The primary objective of this study is to determine if pain and fatigue patients have higher levels of neuroinflammation than HC individuals as measured with [F-18]DPA-714-PET/MRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •18 to 65 years of age
- •Healthy volunteer OR Clinical diagnosis of Multiple Sclerosis (MS) OR Meets 2016 American College of Rheumatology (ACR) case definition criteria for fibromyalgia OR Meets 1994 Fukuda case definition criteria for Chronic Fatigue Syndrome
排除标准
- •Contraindication to MRI
- •Individuals who are unable to participate in the imaging portion due to severity of their medical condition
- •Chronic infectious disease (e.g. HIV, HCV)
- •Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation
- •Diagnosis of cancer, including leukemia
- •Blood or blood clotting disorder
- •Except for individuals with MS, a diagnosis of autoimmune disease is exclusionary
- •Positive urine β-hCG test day of procedure or a serum -hCG test within 48 hours prior to the administration of [18F]DPA-714
- •Currently enrolled in a clinical trial utilizing experimental therapies
研究组 & 干预措施
Healthy Controls
干预措施: DPA-714 PET/MRI (Drug)
Fibromyalgia Subjects
干预措施: DPA-714 PET/MRI (Drug)
Chronic Fatigue Syndrome Subjets
干预措施: DPA-714 PET/MRI (Drug)
Multiple Sclerosis Subjects
干预措施: DPA-714 PET/MRI (Drug)
结局指标
主要结局
Neuroinflammation will be measured in healthy volunteers and compared to neuroinflammation in individuals with pain and fatigue, as measured with [F-18]DPA-714-PET/MRI.
时间窗: 3 years
Quantitative PET measures of TSPO binding in brain regions including cerebral cortex, thalami, and brainstem will be compared between healthy volunteers and symptomatic study participants with pain and/or fatigue.
次要结局
未报告次要终点
研究者
Jonathan E McConathy
M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics
University of Alabama at Birmingham