Advanced MR and PET Imaging in Inflammatory Demyelinating Diseases of the Central Nervous System
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Uptake of C-11 Pittsburgh compound-B (PiB) in white matter myelin
研究概览
简要总结
This purpose of this study is research the usefulness of MRI with PET/CT imaging for measuring brain inflammation and its relation to Multiple Sclerosis (MS).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meet the requirements for one of the case or control groups.
- •MS patients undergoing neurologic evaluation procedures as part of Understanding Sex Differences in Multiple Sclerosis Spectrum of Demyelinating Disorders (IRB# 19-002807) Study or the Mayo Clinic Neurology Multiple Sclerosis Clinic.
- •Control participants without inflammatory-demyelinating diseases of the central nervous system
- •Capacity to sign consent.
排除标准
- •Participants unable to lie down without moving for 20 minutes.
- •Women who are pregnant or cannot stop breast feeding for 24 hours.
- •For all patients and controls, any acute glucocorticoid (e.g., IV methylprednisolone or PO prednisolone) use within 2 weeks is an exclusion to limit medication interaction but preserve possible chronic systemic inflammation interaction with microglia activation metrics. Chronic disease modifying treatments in MS are allowed as these medications are not known to impact microglia activation.
- •Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc., since the quantitative PET data analysis is based on anatomic criteria that are established uniquely for each subject by registration to his/her MRI.
研究组 & 干预措施
Healthy Control Group
Subjects without inflammatory-demyelinating diseases of the central nervous system
干预措施: C-11 ER176 Radiotracer (Drug)
Healthy Control Group
Subjects without inflammatory-demyelinating diseases of the central nervous system
干预措施: C11 Pittsburgh Compound B (Drug)
Healthy Control Group
Subjects without inflammatory-demyelinating diseases of the central nervous system
干预措施: PET/CT scan (Diagnostic Test)
Healthy Control Group
Subjects without inflammatory-demyelinating diseases of the central nervous system
干预措施: MRI (Diagnostic Test)
Multiple Sclerosis Group
Subjects with current diagnosis of Multiple Sclerosis or an InflammatoryDemyelinating Disease of the Central Nervous System will have a PET/CT scan with radiotracer drug C-11 PIB & C-11 ER176
干预措施: C-11 ER176 Radiotracer (Drug)
Multiple Sclerosis Group
Subjects with current diagnosis of Multiple Sclerosis or an InflammatoryDemyelinating Disease of the Central Nervous System will have a PET/CT scan with radiotracer drug C-11 PIB & C-11 ER176
干预措施: C11 Pittsburgh Compound B (Drug)
Multiple Sclerosis Group
Subjects with current diagnosis of Multiple Sclerosis or an InflammatoryDemyelinating Disease of the Central Nervous System will have a PET/CT scan with radiotracer drug C-11 PIB & C-11 ER176
干预措施: PET/CT scan (Diagnostic Test)
Multiple Sclerosis Group
Subjects with current diagnosis of Multiple Sclerosis or an InflammatoryDemyelinating Disease of the Central Nervous System will have a PET/CT scan with radiotracer drug C-11 PIB & C-11 ER176
干预措施: MRI (Diagnostic Test)
结局指标
主要结局
Uptake of C-11 Pittsburgh compound-B (PiB) in white matter myelin
时间窗: Baseline
C-11 Pittsburgh compound-B (PiB) in PET imaging measured by PiB standardized uptake value ratio (SUVr)
Uptake of C-11 ER176 Radiotracer
时间窗: Baseline
C-11 ER176 Radiotracer in TSPO PET imaging measured by ER176 SUVr
次要结局
- Number of subjects with adverse events(2 days)