Non-invasive Nodal Staging in Breast Cancer With Magnetic Resonance Imaging Lymphography Using Gadofosveset
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- The diagnostic performance (sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV)) of axillary MRL in predicting the involvement of metastases
研究概览
简要总结
The aim of this study is to examine the diagnostic performance of gadofosveset enhanced magnetic resonance imaging lymphography (MRL).
The diagnostic performance of MRL will be determined on the basis of a node-to-node matching of imaged nodes to the definitive histopathology. The pathologic examination of the sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) will be regarded as the golden standard for nodal involvement.
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
- •Female patient with histopathologically confirmed breast cancer about to undergo nodal staging.
- •Willing and able to undergo all study procedures
- •Has personally provided written informed consent.
排除标准
- •Contra indications for MRL such as pacemaker, aneurysm clips or severe claustrophobia.
- •Allergy to any of the ingredients of Gadofosveset (Vasovist® /Ablavar®)
- •Being unable to give informed consent in person
- •Acute or chronic severe renal insufficiency (glomerular filtration rate <45 mL/min/1.73m2)
- •Acute renal insufficiency of any severity due to the hepato-renal syndrome.
- •Known (or suspicion of) QT- prolongation
研究组 & 干预措施
Gadofosveset MRL
干预措施: Gadofosveset enhanced MRL of axillary lymph nodes (Drug)
结局指标
主要结局
The diagnostic performance (sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV)) of axillary MRL in predicting the involvement of metastases
时间窗: Participants will be followed from the moment of first out-hospital clinic vistit untill final breast surgery, an expected average of 4 weeks.
The main study parameter will be the diagnostic performace (sensitivity, specificity, NPV and PPV) of the axillary MRL in predicting the involvement of metastases in the investigated lymph nodes. Each node will be scored on MRL as 0= benign, 1=malign. These results will be compared with the histopathological results of the SNLB procedure of ALND procedure on an node by node basis. So the diagnostic performace can be calculated.
次要结局
未报告次要终点