Novel MRI Biomarkers for Monitoring Disease Progression in ALS
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 119
- 试验地点
- 16
- 主要终点
- Change in DTI indices (unitless).
研究概览
简要总结
Routine MRI is normal in motor neuron diseases such as ALS. However, advanced MRI techniques can provide an objective measure of degeneration (a "biomarker") by examining brain structure, wiring, chemistry, and function. We will develop and evaluate novel MRI techniques that could improve our understanding of ALS and provide a means to diagnose it sooner and monitor its progression. Importantly, we expect these techniques to improve how new drugs are tested, which may lead to the more rapid discovery of a treatment for ALS.
Each participant will have 3 MRI scans over a period of 8 months, along with neurological and cognitive evaluations. Study visits will take 2 - 3 hours. MRI is a safe technique that does not involve radiation.
详细描述
Current clinical measures of disease burden have suboptimal sensitivity to disease progression in ALS. A biomarker would play an essential role in the evaluation of novel therapeutics, leading to the realization of effective treatments faster. Magnetic resonance imaging (MRI) holds promise as a non-invasive source of biomarkers in ALS. In this study data is collected from a national imaging platform (the Canadian ALS Neuroimaging Consortium [CALSNIC]) using standardized MRI and clinical protocols.
CALSNIC was founded with the objective to validate MRI biomarkers on a standardized multi-centre platform. CALSNIC is a multidisciplinary group of scientists at 7 centres across Canada. The first CALSNIC study entitled "MRI Biomarkers in ALS" (CALSNIC-1) is ongoing and slated to finish recruitment in 2017.
This study ("Novel MRI Biomarkers for Monitoring Disease Progression in ALS", CALSNIC-2) is a new project that will evaluate novel MRI biomarkers using advanced imaging acquisition and processing methods. The specific aims of CALSNIC-2 are 1) to establish a standardized MRI and clinical protocol across the 7 centres, and 2) to validate MRI measures with clinical measures of disease burden and progression.
It is anticipated that the project will lead to the discovery of MR-based biomarkers of cerebral degeneration that can be applied across different centres and hence, can assist with drug development. Secondly, this project will expand CALSNIC to include more centres and provide opportunities for collaborative and multidisciplinary translational research on a national scale.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Patients with a suspected or confirmed diagnosis as described in Study Populations
- •For those with a diagnosis of ALS, patients will be considered with an El Escorial classification of suspected, possible, probable, probable lab-supported, and definite ALS.
- •Patients 18 years of age or older
- •Healthy controls over the age of
- •Be able to lie in an MRI machine for approximately 60 minutes
排除标准
- •Subjects with psychiatric/CNS illnesses such as Major Depressive Disorder, Schizophrenia, and Bipolar disorder.
- •Subjects with significant head injury or other neurological disease (stroke, brain tumour).
- •Subjects ineligible for MRI investigation due to a pacemaker or other metallic foreign body.
结局指标
主要结局
Change in DTI indices (unitless).
时间窗: 8 months
This primary analysis will evaluate white matter integrity at baseline and specified follow up periods. Patients and controls scans will be compared.
Change in cortical thickness in millimetres.
时间窗: 8 months
This primary analysis will evaluate neuronal integrity at baseline and specified follow up periods. Patients and controls scans will be compared.
次要结局
未报告次要终点