Thoracoscopic Internal Mammary Sentinel Node Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as thoracoscopic sentinel lymph node biopsy, may help find breast cancer that has spread to lymph nodes between the breasts. It may also help doctors plan the best treatment.
PURPOSE: This clinical trial is studying how well thoracoscopic sentinel lymph node biopsy finds sentinel lymph nodes that are located between the breasts in patients with stage I or stage II breast cancer.
详细描述
OBJECTIVES:
- Determine the occurrence rate of internal mammary sentinel lymph nodes in patients with medially or centrally located stage I or II breast cancer.
- Determine the safety, feasibility, and success rate of thorascopic internal mammary sentinel lymph node biopsy in these patients.
- Determine the rate of metastatic disease in internal mammary sentinel lymph nodes obtained thoracoscopically in these patients.
OUTLINE: Patients undergo standard axillary sentinel lymph node dissection during surgery (i.e., lumpectomy or mastectomy). Patients receive a radioactive tracer (i.e., technetium Tc 99m sulfur colloid) and isosulfan blue by peritumoral injection for identification of the axillary and internal mammary sentinel lymph nodes (IMSLN). Identified axillary sentinel lymph nodes are dissected. Identified IMSLNs are removed through the lumpectomy/mastectomy incision, if accessible. If they are not accessible, patients undergo thorascopic IMSLN biopsy to remove the nodes.
All removed sentinel lymph nodes (axillary or internal mammary) are examined for gross and microscopic carcinoma for future therapy planning.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sentinel Lymph Node Biopsy
干预措施: Isosulfan blue (Drug)
Sentinel Lymph Node Biopsy
干预措施: Axillary Lymph Node Dissection (Procedure)
Sentinel Lymph Node Biopsy
干预措施: Surgery (Procedure)
Sentinel Lymph Node Biopsy
干预措施: Sentinel Lymph Node Biopsy (Procedure)
Sentinel Lymph Node Biopsy
干预措施: Thoracoscopic Surgery (Procedure)
Sentinel Lymph Node Biopsy
干预措施: Technetium Tc 99m Sulfur Colloid (Radiation)
结局指标
主要结局
Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy
时间窗: 5 years
Rate of Metastatic Disease in Internal Mammary Sentinel Lymph Nodes
时间窗: 5 years
Number of Patients With Identifiable Internal Mammary Sentinel Lymph Nodes
时间窗: 5 years
次要结局
未报告次要终点