NCT01597999Unknown4 期
Accuracy of Magnetic Resonance Imaging (MRI) in Predicting Aggressiveness of Early Breast Cancer According to Molecular Subtypes Identified by ER PR and HER-2 Status
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- study the benefits of DCE-MRI using Gadovist in prognostic determination of early invasive breast cancer
研究概览
简要总结
This study examines the additional benefits of magnetic resonance imaging (MRI) with Gadovist in early breast cancer with poor prognostic features.
详细描述
Dedicated Contrast-enhanced Magnetic Resonance Imaging (DCE-MRI)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with invasive ductal carcinoma
- •Patients undergoing DCE-MRI scan which are assessed according to BI-RADS lexicon
- •Breast cancer patients with pathological diagnosed invasive ductal carcinoma with hormonal receptor (ER, PR and HER-2) response
- •Patients who have signed on informed consent form Patients will undergo MRI imaging and the physicians will practice according to practice guidelines.
排除标准
- •Patients under 18 years old or during pregnancy
- •Patients with MRI's contraindications e.g. patients with cardiac pacemaker or are allergic to MRI contrast agent Patients with unstable clinical abnormality and might get unexpected clinical treatment
结局指标
主要结局
study the benefits of DCE-MRI using Gadovist in prognostic determination of early invasive breast cancer
时间窗: 1 year
The benefits of breast tumor diagnosis from DCE-MRI in early invasive breast cancer with poor prognostic features
次要结局
- ascertain the accuracy of pre-operative DCE-MRI in terms of detection and characterization of breast cancer, as compared to tissue biopsy.(1 year)
研究者
研究点 (2)
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