A Pilot Study of Gadopiclenol for Imaging Central Nervous System (CNS) Tumors at Point of Care Magnetic Resonance Imaging (MRI)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 10
- 主要终点
- Visibility of lesions
研究概览
简要总结
The purpose of this pilot study is to compare a standard of care MRI scan to a non-standard of care MR imaging with portable (0.064 Tesla) MRI following the administration of non-SOC contrast called Gadopiclenol on 10 subjects with known brain tumors.
Participants will be randomized to receive either standard MRI or portable MRI first following contrast injection
详细描述
This study compares a routine MRI scan with a new portable MRI scanner known as the "Hyperfine" using a contrast dye called Gadopiclenol, the contrast is FDA approved. If participants choose to participate in this study, they will receive two MRI scans on the same day. One on the traditional standard of care MRI scanner and the other on the new portable Hyperfine MRI. The Hyperfine MRI scanner is not FDA approved due to being a very low risk medical device. However, the device is compliant with all of the FDA requirements regarding design control regulations and risk analysis. Participants will only receive one contrast injection that will be used for both scans. The selection of which scan is given first will be randomly selected (50/50 chance). Participation in this study will last two days. The first day participants will receive both MRI scans and the second day participants will receive a phone call from the research staff to check on them.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
3T Contrast Enhanced Images First
干预措施: CE MRI on 0.064T Scanner (Device)
3T Contrast Enhanced Images First
干预措施: Gadopiclenol (Drug)
0.064 Contrast Enhanced Images First
干预措施: CE MRI on 0.064T Scanner (Device)
0.064 Contrast Enhanced Images First
干预措施: Gadopiclenol (Drug)
结局指标
主要结局
Visibility of lesions
时间窗: 1 Day
Visibility of lesions and diagnostic capabilities of 0.068T MRI
次要结局
未报告次要终点
