Axillary Reverse Mapping in Breast Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Map arm lymphatic drainage system in the axilla
研究概览
简要总结
The purpose of this study is to map the arm lymphatic drainage system in the axilla with blue dye and the breast drainage system with a radioactive material. By identifying the arm lymphatics they can be protected during surgery and this may decrease the occurrence of lymphedema. The information obtained in this study may provide us with better surgical techniques to identify and protect the arm lymphatic drainage system in the axilla.
详细描述
This study is a non-randomized Phase II study of the Axillary Reverse Mapping (ARM) procedure for patients presenting with breast cancer requiring lymph node evaluation. The study will enroll 100 subjects, and will have two study arms: one for patients requiring only the SLNB procedure (roughly 67% of enrollees), and one for patients requiring a full ALND (roughly 33% of enrollees). For the analysis of study efficacy, each arm will be compared to its procedure-appropriate historical control for evidence of decrease in the 1-year lymphedema rate among patients undergoing SLNB or ALND.
Additional data will be collected on the treatment population's (a) variability in location of arm lymphatics, and (b) incidence of SLN crossover with arm lymphatics, along with success-rate data for identifying SLNs and arm lymphatics during SLNB and/or ALND. This additional data will add to our level of knowledge and experience regarding lymph node surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19-100 years old
- •Not pregnant or breastfeeding
- •Breast cancer requiring LN evaluation for the breast
- •Willing participation following an informed consent process
排除标准
- •Patient < 19 y/o or > 100 y/o
- •Pregnant or breastfeeding
- •Allergy to blue dye
- •Locally advanced axillary disease
- •History of receiving neoadjuvant chemotherapy treatment
- •Prior axillary surgery or radiation therapy
结局指标
主要结局
Map arm lymphatic drainage system in the axilla
时间窗: 4 years
次要结局
- Decrease the occurrence of lymphedema(4 years)