Phase III Trail of Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Positive
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB
研究概览
简要总结
In addition to the axillary lymph nodes, the internal mammary lymph nodes (IMLNs) drainage is another important lymphatic channel of the breast. The status of IMLNs also provides important prognostic information for breast cancer patients. The technical evolvements of sentinel lymph node biopsy (SLNB) and lymphoscintigraphy provided a less invasive method for assessing IMLNs than surgical dissection. Recently, many study concerning IMSLNB was performed in the patients with clinically negative axillary nodes. However, previous published studies concerning patients with breast cancer who all underwent a radical mastectomy have shown that IMLN metastases are mostly found concomitantly with axillary metastases. For this reason, IM-SLNB is even more important for clinically axillary node-negative patients. To our knowledge, this is the first attempt of the IM-SLNB in early breast cancer patients with clinically positive axillary nodes.
详细描述
OBJECTIVES:
- Determine the impact of routinely performed internal mammary sentinel lymph node biopsy on the systemic and locoregional treatments plan.
- Evaluate the metastasis rate of internal mammary sentinel lymph nodes in patients with clinically axillary node-positive.
- Draw the learning curve of internal mammary sentinel lymph node biopsy.
OUTLINE:
3~18 hours before surgery, under ultrasonographic guidance, 0.5~1.0 mCi 99mTc-labeled sulfur colloid in sterile saline (total volume 0.2~2.0 mL) is injected intraparenchymally into 2 quadrants of breast. Subsequently, lymphoscintigraphy is performed 0.5~1.0 hour before surgery. internal mammary sentinel lymph node biopsy is performed during the surgery and the internal mammary sentinel lymph nodes were sent to histologic examination.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •primary breast cancer
- •clinically axilla-positive
排除标准
- •enlarged internal mammary nodes by imaging
研究组 & 干预措施
clinically positive axillary nodes
3~18 hours before surgery, under ultrasonographic guidance, 0.5~1.0 mCi 99mTc-SC in sterile saline (total volume 0.2~2.0 mL) is injected intraparenchymally into 2 quadrants of breast. Subsequently, LSG is performed 0.5~1.0 hour before surgery. Methylthioninium was injected intraparenchymally. IM-SLNB is performed during the surgery and the IMSLNs were sent to histologic examination
干预措施: IM-SLNB (Procedure)
clinically positive axillary nodes
3~18 hours before surgery, under ultrasonographic guidance, 0.5~1.0 mCi 99mTc-SC in sterile saline (total volume 0.2~2.0 mL) is injected intraparenchymally into 2 quadrants of breast. Subsequently, LSG is performed 0.5~1.0 hour before surgery. Methylthioninium was injected intraparenchymally. IM-SLNB is performed during the surgery and the IMSLNs were sent to histologic examination
干预措施: 99mTc-SC (Radiation)
clinically positive axillary nodes
3~18 hours before surgery, under ultrasonographic guidance, 0.5~1.0 mCi 99mTc-SC in sterile saline (total volume 0.2~2.0 mL) is injected intraparenchymally into 2 quadrants of breast. Subsequently, LSG is performed 0.5~1.0 hour before surgery. Methylthioninium was injected intraparenchymally. IM-SLNB is performed during the surgery and the IMSLNs were sent to histologic examination
干预措施: Histologic Examination (Device)
clinically positive axillary nodes
3~18 hours before surgery, under ultrasonographic guidance, 0.5~1.0 mCi 99mTc-SC in sterile saline (total volume 0.2~2.0 mL) is injected intraparenchymally into 2 quadrants of breast. Subsequently, LSG is performed 0.5~1.0 hour before surgery. Methylthioninium was injected intraparenchymally. IM-SLNB is performed during the surgery and the IMSLNs were sent to histologic examination
干预措施: LSG (Device)
clinically positive axillary nodes
3~18 hours before surgery, under ultrasonographic guidance, 0.5~1.0 mCi 99mTc-SC in sterile saline (total volume 0.2~2.0 mL) is injected intraparenchymally into 2 quadrants of breast. Subsequently, LSG is performed 0.5~1.0 hour before surgery. Methylthioninium was injected intraparenchymally. IM-SLNB is performed during the surgery and the IMSLNs were sent to histologic examination
干预措施: Methylthioninium (Drug)
结局指标
主要结局
Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB
时间窗: 1 year
Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB
次要结局
- Metastasis Rate of IMSLNs(1 year)
- Visualization Rate of IMSLNs(1 year)
研究者
Yongsheng Wang
Director, Head of Breast Cancer Center, Principal Investigator, Clinical Professor
Shandong Cancer Hospital and Institute