Upper Extremity Lymphatic Mapping for Breast Cancer Patients: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Number and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast).
研究概览
简要总结
This study is being done to see if lymph nodes that drain the arm also drain the breast. An axillary lymph node dissection removes lymph nodes under the arm. It is done to help prevent cancer cells from spreading to the rest of the body. Usually, about 12 to 15 nodes are removed. They are then examined to see if they have cancer cells. Removing these lymph nodes has some side effects. The most common is lymphedema. This is the build-up of fluid in the arm. This study will tell us if it may be possible in the future to identify lymph nodes that just drain the arm. Leaving those nodes may help to reduce the rate of lymphedema for future patients.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females with Stage II invasive breast cancer and documented axillary metastases by core biopsy, clinical examination, or fine-needle aspiration who are scheduled to undergo an ALND.
- •Females > 21 years of age
排除标准
- •Prior ipsilateral axillary surgery
- •Prior ipsilateral axillary radiation
- •Prior ipsilateral breast cancer
- •Prior ipsilateral breast radiation
- •Allergy to isosulfan blue dye
- •History of ipsilateral upper extremity lymphedema
- •Prior history of surgical excision of the upper outer quadrant of the ipsilateral breast
- •Prior history of neoadjuvant chemotherapy for current breast cancer
- •Bulky axillary disease at presentation (N2)
结局指标
主要结局
Number and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast).
时间窗: 2 years
次要结局
未报告次要终点