Magnetic Resonance Imaging Using Innovative Pulse Sequences
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Number of Head Images Successfully Collected
研究概览
简要总结
The purpose of the study is to collect in vivo human image data to demonstrate neurological magnetic resonance imaging (MRI) of subjects using short pulse sequences.
详细描述
This is a single-site; open-label, prospective research Study involving human subjects. There will be no comparative efficacy or safety analysis and therefore no randomization
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Subject must be at least 18 years of age
- •Subject must be willing and able to undergo verbal and written informed consent
- •Subject must have a clinical indication for a head MRI with and without Gadolinium-based contrast agent administration
排除标准
- •Subjects who have any of the conditions below at the time of the enrollment or scan session are excluded from this study. Further, should it be determined by study staff that an enrolled subject meets any of the conditions below during the course of the study, the subject will be removed from the study.
- •Any contraindication to an MRI scan per the policy of Spectrum Health
- •Any contraindication to administration of an MRI contrast agent per the policy of Spectrum Health
- •Off-label utilization of contrast agents administered for the subject's clinical exam
研究组 & 干预措施
pulse sequence software
The central aim of this study is to acquire a set of images and associated technical and clinical information to facilitate regulatory submission of the pulse sequences being studied by GEHC. Segment 1 allows to collect a minimum of 10 subjects then evaluate if additional scans/enrollment needed Segment 2 will allow an additional 90 subjects if data needed
干预措施: pulse sequences (Device)
结局指标
主要结局
Number of Head Images Successfully Collected
时间窗: 6-months
Collect head human images and associated technical and clinical information to demonstrate neurological magnetic resonance imaging of subjects using short pulse sequence.
次要结局
未报告次要终点