Low-dose Imaging Technique (LITE) MRI Gadavist® (Gadobutrol)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Low-dose Lesion Enhancement
研究概览
简要总结
The purpose of this study is to compare the diagnostic accuracy of a breast MRI when using a smaller dose of contrast compared to a full dose of contrast.
Each patient will be injected with a low-dose and standard dose of Gadavist® acquired on two separate days. Both low-dose and standard-dose images for each patient will allow matched comparison for comprehensive quantitative evaluation. To evaluate these diagnostic methods we need volunteers who are willing to allow us to take a number of different MRI pictures of their breasts. The scans we are asking you to volunteer for now is for research purposes only and will have no effect on the medical care you receive from your doctors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between the ages of 18-80
- •Women with a suspected or biopsy proven enhancing lesion
排除标准
- •Women with a history of adverse reactions to contrast media
- •Women with GFR below 30 mL/min/1.73m2
- •Women who are pregnant or breastfeeding
结局指标
主要结局
Low-dose Lesion Enhancement
时间窗: Through study completion, an average of 1 year
Readers will initially be provided with two MIP images and asked to decide on presence or absence of significant enhancement. The two MIP images will be created from the low dose images and the standard dose images respectively.
次要结局
未报告次要终点