Phase II Trail of Removing Sonographic Abnormal Lymph Node in Sentinel Lymph Node Biopsy of Breast Cancer Patient
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- False negative rate of sentinel node biopsy if sonographic abnormal node not be removed
研究概览
简要总结
- This is a phase II, prospective, single-center, non-randomized, non-controlled study.
- Sentinel lymph node biopsy (SNB) is a standard staging procedure in early breast cancer. The potentially increasing false negative rate of SNB was concerned if the sonographic abnormal node was not excised. The aim of this study was to evaluate the accuracy of SNB in breast cancer with sonographic abnormal axillary lymph nodes.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •histologically confirmsed primary breast cancer by core neelde biopsy or excisional biospy
- •abnormal axillary lymph node was found by ultrasound examination before SLNB (abnormal nodes were defined as completely hypoechoic node, asymmetric focal hypoechoic node, cortical lobulation and cortical thickness >3mm)
- •ultrasound-guided FNA cytology of these nodes were performed
- •the result of FNA cytology was negative (no tumour cell was found)
- •patient planed to perform SLNB
排除标准
- •pathological diagnosed ductal carcinoma in situ by excisional biospy
- •abnormal axillary lymph node was found by ultrasound examination but FNA cytology of these nodes were not performed
- •the result of FNA cytology was positive (tumour cell was found)
- •T4d tumour
- •patient has recieved neo-adjuvant system therapy
研究组 & 干预措施
negative FNA result of abnormal node
Axillary ultrasound examination was undergone for all breast cancer patients before sentinel lymph node biopsy (SLNB). If abnormal axillary lymph node was found, ultrasound-guided FNA cytology of these nodes were performed. The abnormal nodes were defined as completely hypoechoic node, asymmetric focal hypoechoic node, cortical lobulation and cortical thickness >3mm. Patients with negative results of FNA would undergo SLNB. Technetium-99m-labeled Rituximab was used for lymphatic mapping. Before the SLNB operation, a hookwire was placed at the suspicious axillary lymph node by ultrasound guidance. In the SLNB operation, radioactive nodes and wire-localized nodes were removed and labeled separately for pathological examination.
干预措施: Wire-localized abnormal node (Procedure)
结局指标
主要结局
False negative rate of sentinel node biopsy if sonographic abnormal node not be removed
时间窗: one week after sentinel node biopsy
次要结局
未报告次要终点
研究者
Tao OUYANG
Chairman of Breast Center
Peking University