Novel Imaging Markers of Innate Immune Activation in Secondary Progressive Multiple Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Signal change on T1-weighted and 3D UTE MRI brain (and upper cervical cord) before and 96 hours (±24 hours) after ferumoxytol administration
研究概览
简要总结
This pilot study takes the innovative approach of using ultrasmall superparamagnetic iron oxide (USPIO) nanoparticle enhanced MRI to measure activity of the innate immune system within MS lesions. Activity of innate immunity has been hypothesized as one of the critical pathologic processes underpinning neurologic worsening in progressive MS. As such, in the short term this project proposes to investigate USPIO uptake in SPMS lesions as a promising in vivo imaging biomarker for chronic-active lesions, as distinguished from chronic-inactive lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age 35 to 65 years
- •Clinically diagnosed with secondary progressive multiple sclerosis (SPMS) (2017 McDonald Criteria)
- •Worsening 25 foot walk time (worsening SPMS cohort) over the preceding 2 years.
- •Ambulatory with ability to walk at least 20 meters without rest, with or without aid
- •Ability and willingness to attend study visits and complete the study
排除标准
- •Clinically diagnosed with relapsing remitting multiple sclerosis (RRMS), primary progressive multiple sclerosis (PPMS), clinical isolated syndrome (CIS), or radiologically isolated syndrome (RIS)
- •Clinical MS relapse and/or new MRI lesion(s) within the preceding 2 years
- •Positive pregnancy test
- •Gadolinium contrast allergy
- •Acute or chronic kidney disease with eGFR <30 ml/min/1.73m2
- •Pacemaker or other MRI contraindications per American College of Radiology guidelines
- •Intravenous iron sensitivity
- •Serum ferritin and transferrin saturation above age-adjusted upper limit of normal (if serum ferritin is above normal, but transferrin saturation is normal, the subject is NOT excluded)
研究组 & 干预措施
SPMS Cohort
Subjects will undergo MR imaging of the brain and cervical spine for pre- and post-administration of gadoteridol (0.2 mL/kg), then pre- and post-administration of ferumoxytol (4 mg/kg). Scans will be obtained over the course of two separate imaging visits.
干预措施: Gadoteridol (Drug)
SPMS Cohort
Subjects will undergo MR imaging of the brain and cervical spine for pre- and post-administration of gadoteridol (0.2 mL/kg), then pre- and post-administration of ferumoxytol (4 mg/kg). Scans will be obtained over the course of two separate imaging visits.
干预措施: MRI Brain and Cervical Spine (Diagnostic Test)
SPMS Cohort
Subjects will undergo MR imaging of the brain and cervical spine for pre- and post-administration of gadoteridol (0.2 mL/kg), then pre- and post-administration of ferumoxytol (4 mg/kg). Scans will be obtained over the course of two separate imaging visits.
干预措施: Ferumoxytol infusion (Drug)
结局指标
主要结局
Signal change on T1-weighted and 3D UTE MRI brain (and upper cervical cord) before and 96 hours (±24 hours) after ferumoxytol administration
时间窗: 96 hours ±24 hours
次要结局
- Incidence of treatment-emergent adverse events (safety and tolerability)(96 hours ±24 hours)