ARM: Axillary Reverse Mapping
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Assess lymphedema rates
研究概览
简要总结
It has been hypothesized that the proximity of the anatomic locations of the arm lymphatic drainage system to the breast lymphatic system in the axilla put the arm lymphatics at risk for disruption during a sentinel lymph node biopsy (SLNB) and/or axillary lymph node dissection (ALND). Therefore, mapping the drainage of the arm in addition to the drainage of the breast during the procedure would potentially decrease the incidence of arm lymphatic disruption and subsequent development of lymphedema while providing adequate axillary breast nodes needed for staging.
详细描述
Patients will receive an injection of 1.0 mCi of technetium-99m sulfur colloid that will be injected into the sub-dermal subareolar aspect of the affected breast.
On the day of surgery, if the radioactive SLN cannot be located using the gamma probe prior to incision, lymphazurin or methylene blue dye will be used in the breast in the subareolar plexus at the discretion of the surgeon for assistance in identifying the sentinel nodes. This contingency, expected to occur < 3% of the time, will be used since locating the SLN for staging is of greater importance than the study. If radioactive isotope is sufficient to identify the sentinel node draining from the breast, then the blue dye will be injected dermally in the upper inner arm along the bicipital groove of the ipsilateral arm in order to locate the draining lymphatics from the arm. No more than 5cc of blue dye will be injected in any of the above mentioned scenarios. The site of all injections (radioactivity and/or blue dye) will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 - 100 years old
- •Not pregnant or breastfeeding
- •Diagnosis of breast cancer requiring LN evaluation for ipsilateral or contralateral breast or prophylactic mastectomy
- •Willing participation after obtaining informed consent
排除标准
- •< 18 or > 100 years of age
- •Pregnant or breastfeeding
- •Blue dye allergy
- •Cosmetic allergy
- •History of primary lymphedema
- •Prior breast augmentation
结局指标
主要结局
Assess lymphedema rates
时间窗: Four Years
The primary objective of this study is to assess and test the lymphedema rates six times at the following intervals: Pre-surgery - baseline, at 6 months, and yearly for 4 years. Since the historical control rates are different (5% for SLNB only and 13% for ALND with or without SLNB) two tests will be performed.
次要结局
- Identification of breast sentinal lymph node and arm lymphatics(at time of surgery)
- Characterization of location(at time of surgery)
- Protection of the arm(at time of surgery)
- Occurrence of crossover(at time of surgery)