Measuring Brain Health Using Low-Field Portable MRI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- WMH graded on a low-field WMH scale
研究概览
简要总结
The purpose of this study is to develop a new grading scale and utilize automated segmentation for measurement of White Matter Hyperintensity (WMH) volume using a low field MRI.
详细描述
This study will take place in one visit, if feasible. This visit will take approximately 2 hours. (Alternatively, the visit can be split over two visits if the subject cannot tolerate two consecutive scans. The pMRI and 3T MRI can occur up to one month apart.)
The purpose of this study is to create both a qualitative lowfield WMH scale that can be used widely and a machine learning enabled quantitative measurement of WMH for more sophisticated applications. To ensure the reliability of these WMH measurement systems, participants will receive both a pMRI and high-field 3T MRI at a single study visit for the purpose of comparing WMH measurements against a gold standard (3T MRI). Using the Delphi method, an expert panel of pMRI researchers will develop the low-field WMH grading scale, iteratively refine it, and validate it within this cohort. Parallel to this, advanced machine learning methodologies will be utilized in this cohort, allowing for precise quantification of WMH volume on pMRI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •One vascular risk factor, from the following:
- •Hypertension (defined as taking an antihypertensive medication)
- •Hyperlipidemia (defined as taking a statin or PCSK9 inhibitor)
- •Diabetes (defined as taking a medication to prevent hyperglycemia)
排除标准
- •1. History of stroke
- •History of dementia or other cognitive impairment
- •Pacemaker or other MRI contraindications according to the American College of Radiology guidelines
研究组 & 干预措施
pMRI and 3T MRI
Participants will receive both a pMRI and high-field 3T MRI at a single study visit for the purpose of comparing WMH measurements against a gold standard (3T MRI).
干预措施: Portable low-field MRI (pMRI) (Device)
pMRI and 3T MRI
Participants will receive both a pMRI and high-field 3T MRI at a single study visit for the purpose of comparing WMH measurements against a gold standard (3T MRI).
干预措施: 3T MRI (Device)
结局指标
主要结局
WMH graded on a low-field WMH scale
时间窗: 2 hours
Each pMRI scan will be evaluated by two readers experienced in the adjudication of WMH and the high-field 3T MRI will be adjudicated by a board certified neuroradiologist. WMH will be graded on a low-field WMH scale as minimal, moderate, or severe. The low-field WMH scale will be derived by an expert panel consisting of the study investigators and two more neurologists, a neuroradiologist, and neuropsychologist. Investigators will employ the Delphi method to harness the collective expertise of this panel in developing the novel grading scale.
次要结局
- WMH lesion load (in mm3)(2 hours)