Non-invasive Nodal Staging in Breast Cancer With MRI Lymphography Using Gadofosveset; a Pilot-study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The accuracy (sensitivity, specificity, NPV and PPV) of the MRI in predicting the involvement of metastases
研究概览
简要总结
The aim of this pilot-study is to examine the accuracy of gadofosveset enhanced MRI compared to current nodal staging methods.
The accuracy 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 SNLB or 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
- •Patient with histopathologically confirmed invasive breast cancer about to undergo nodal staging.
- •Tumor must be a T2 according the TNM 6-classification.
- •The ultrasound of the axilla must be suspect for nodal metastases.
- •Willing and able to undergo all study procedures
- •Has personally provided written informed consent.
排除标准
- •History of prior chemotherapy
- •History of prior radiotherapy of the surrounding areas of the axilla.
- •Contra indications for MRI 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 <30 mL/min/1.73m2).
- •Acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
研究组 & 干预措施
Gadofosveset enhanced MRI Axilla
干预措施: Gadofosveset contrast agent enhanced MRI Axilla (Drug)
结局指标
主要结局
The accuracy (sensitivity, specificity, NPV and PPV) of the MRI 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 accuracy (sensitivity, specificity, NPV and PPV) of the MRI in predicting the involvement of metastases in the investigated lymph nodes. Each node will be scored on MRI 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 accuray can be calculated.
次要结局
未报告次要终点