Feasibility of Lymphatic Mapping of Second Echelon Lymph Nodes With Methylene Blue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- The number of subjects in whom a secondary echelon lymph node is identified
研究概览
简要总结
The investigators plan to study the ability to identify the lymph nodes beyond the sentinel lymph node that may harbor cancer using methylene blue dye.
详细描述
After lymphatic mapping of the SLN with Tc-99 sulfur colloid only, the second-echelon lymphatic mapping was then performed with methylene blue dye by injecting the SLN with 0.05-0.10 cc non dilute methylene blue and tracing via the efferent lymphatic channel to the second echelon lymph node (Figure 1). For our initial patients a 27 gauge needle and 3cc syringe was utilized but this was modified over the study to a 30 gauge needle and 1cc syringe. The blue efferent lymphatic was traced with minimal spreading of the surrounding tissue to visualize its drainage into the next lymph node(s). A second echelon lymph node was considered any blue lymph node or any lymph node with blue dye leading directly into it. The number of second echelon lymph nodes was recorded. The second-echelon lymph node(s) was not removed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed primary cutaneous melanoma located on the extremity or trunk
- •Patients with clinically stage I-II melanoma
- •Histologically confirmed invasive ductal or lobular carcinoma
- •Patient undergoing surgical treatment of breast primary and sentinel lymph node biopsy- clinically node negative
排除标准
- •Melanoma located on the head or neck, uveal or mucosal
- •Previous surgery or radiation in or near the sentinel lymph node biopsy nodal basin
- •Preoperative biopsy proven regional lymph node involvement
- •Failure of lymphatic mapping with radioactive colloid
- •Women who are pregnant or nursing
- •Prior ipsilateral axillary surgery or radiation
- •Inflammatory breast cancer
- •No lymph node identified in the ipsilateral breast during pathologic review of the mastectomy specimen
- •Stage IV breast cancer
研究组 & 干预措施
Methylene Blue
1% Methylene Blue - 1 ml. Methylene blue dye injection of sentinel lymph node
干预措施: Methylene blue dye injection of sentinel lymph node (Procedure)
结局指标
主要结局
The number of subjects in whom a secondary echelon lymph node is identified
时间窗: one year
次要结局
未报告次要终点
研究者
James W. Jakub
Breast and Melanoma Surgery Section Head
Mayo Clinic