Application of the Inhomogeneous Magnetisation Transfer MRI (ihMT) Technique, a New Myelin-specific MRI Technique, in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Magnetic transfert (MT) at 1.5TMRI
研究概览
简要总结
The development of in vivo biomarkers sensitive to myelin disruption represents a major clinical need to be able to monitor the demyelination processes as well as the effect of remyelinating therapies in multiple sclerosis. The investigators recently proposed a technique, derived from the conventional magnetisation transfer (MT): inhomogeneous Magnetisation Transfer (ihMT). In preliminary studies, this simple-to-implement and robust technique has shown great sensitivity for evaluating the demyelination processes. The goal of the project is to evaluate the ability of ihMT to measure and describe the spontaneous demyelination and remyelination processes involved in active lesions in a population of patients with MS at the the disease onset.
详细描述
The development of in vivo biomarkers sensitive to myelin disruption (demyelination and remyelination) represents a major clinical need to be able to monitor the demyelination processes as well as the effect of remyelinating therapies in multiple sclerosis. The investigators recently proposed a technique, derived from the conventional magnetisation transfer (MT): inhomogeneous Magnetisation Transfer (ihMT). In preliminary studies, this simple-to-implement and robust technique has shown great sensitivity for evaluating the demyelination processes. The goal of the project is to evaluate the ability of ihMT to measure and describe the spontaneous demyelination and remyelination processes involved in active lesions in a population of patients with MS at the the disease onset.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Patients and Controls :
- •Adult patient, male and female, age 18 to 45
- •Patient affiliated with health insurance coverage,
- •Patient who signed a free and informed consent after receiving detailed, understandable and honest information,
- •For patients only :
- •Patient with relapsing-remitting multiple sclerosis according to the McDonald 2010 criteria or progressive
- •Patients treated or not treated with first-line disease modifying therapy
- •Detection of at least one post-Gadolinium injection active lesion identified on the initial brain MRI (T0) or a chronic active lesion (PRL: Paramagnetic rim lesions)
排除标准
- •For patients only :
- •Patients with a progressive form of MS other than the early relapsing-remitting form (primary progressive or secondary progressive)
- •For Patients and Controls :
- •Patients with the usual contraindications for MRI (pacemaker, agitation, metal shards, claustrophobia)
- •Patients at risk of non-compliance to the exam: basic problems with understanding, confusion, involuntary movements, poor tolerance of prolonged supine position
- •Patients who are unable to give their consent: problems with understanding, lack of vigilance, confusion
- •Woman who is pregnant and breastfeeding
- •Patients with a history of neurological or psychiatric condition
- •Patients under guardianship or trusteeship
研究组 & 干预措施
experimental group 3T
Population of patients with myelin syndrome (MS) at the the disease onset with active lesions inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T will be performed.
干预措施: inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T (Device)
control group 3T
inhomogeneous Magnetisation Transfer (ihMT) sequence will be performed. inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T will be performed.
干预措施: inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T (Device)
experimental group 1.5T
Population of patients with myelin syndrome (MS) at the the disease onset with active lesions inhomogeneous Magnetisation Transfer (ihMT) sequence will be performed.
干预措施: inhomogeneous Magnetisation Transfer (ihMT) sequence (Device)
control group 1.5 T
healthy volunteers matched in sex and age inhomogeneous Magnetisation Transfer (ihMT) sequence will be performed.
干预措施: inhomogeneous Magnetisation Transfer (ihMT) sequence (Device)
结局指标
主要结局
Magnetic transfert (MT) at 1.5TMRI
时间窗: 1 year
relative signal variations of the conventional magnetization transfer (MT)
ihMTR ratio at 1.5TMRI
时间窗: 1 year
ihMT 3D technique at 1.5TMRI on active lesions with baseline measurements
Myelin water fraction at 1.5TMRI
时间窗: 1 year
myelin water fraction (MWF), an MRI biomarker of myelin, in new MS lesions
次要结局
- Evaluate the predictive value of ihMT(1 year)
- ihMTR ratio at 3TMRI(1 year)