Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Regional brain distribution of radiolabeled white blood cells
研究概览
简要总结
This study will use brain Positron Emission Tomography/ Magnetic Resonance Imaging (PET/MRI) and an investigational radioactive drug called [Zr-89]oxine to track the location of white blood cells (also called leukocytes) in the body. PET/MRI will be used to visualize labeled white blood cells and determine if they enter the central nervous system in conditions associated with brain inflammation (also called neuroinflammation). By better understanding the role of neuroinflammation in fibromyalgia, chronic fatigue syndrome, and multiple sclerosis, the investigator hopes to be able to better diagnose and treat patients in the future.
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
- •1.18 to 65 years of age 2.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 pregnancy test day of procedure or a serum pregnancy test within 48 hours prior to the administration of Zirconium-89 Oxinate-4-labeled leukocytes
- •Currently enrolled in a clinical trial utilizing experimental therapies
- •Contraindication to gadolinium based contrast agents
研究组 & 干预措施
Healthy Controls
干预措施: [Zr-89]Oxine-labeled leukocytes PET/MRI (Drug)
Fibromyalgia
干预措施: [Zr-89]Oxine-labeled leukocytes PET/MRI (Drug)
Chronic Fatigue Syndrome
干预措施: [Zr-89]Oxine-labeled leukocytes PET/MRI (Drug)
Multiple Sclerosis
干预措施: [Zr-89]Oxine-labeled leukocytes PET/MRI (Drug)
结局指标
主要结局
Regional brain distribution of radiolabeled white blood cells
时间窗: 3 years
Descriptive statistics (means and standard deviations) of standardized uptake values (SUVs) will be presented for the patient groups and healthy controls in the following regions: whole brain, gray matter, white matter, atlas-based regions of interest, and lesions (MS patients only). Normality of the SUV distribution will be tested using Shapiro-Wilk tests, and the data will be transformed to normal distribution if necessary.
次要结局
未报告次要终点
研究者
Jonathan E McConathy
MD, PhD, Director for the Division Molecular Imaging and Therapeutics
University of Alabama at Birmingham