ARM: Axillary Reverse Mapping, A Prospective Study
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Occurrence of lymphedema by the first year following surgery
研究概览
简要总结
We hypothesize that variations in anatomic location of the arm lymphatic drainage system put the arm lymphatics at risk for disruption during a SLNB and / or ALND. Therefore, mapping the drainage of the arm during the procedure would decrease the likelihood of inadvertent disruption of the lymphatics and the subsequent development of lymphedema. A combination of radioactivity and blue dye will be used.
详细描述
Mapping Procedure:
Each patient will receive an injection of 1.0 mCi of technetium-99m sulfur colloid into the normal breast tissue surrounding the primary cancer or biopsy cavity directed subareolar or around the tumor.
If the radioactive SLN cannot be located prior to incision via gamma probe then the blue dye will be used in the breast either in the subareolar plexus or peritumorally at the discretion of the surgeon. For this contingency (expected to occur <3% of the time), the blue dye will be used in the breast (and NOT the arm), as the prime concern is locating the SLN for staging.
If the blue dye is unnecessary to find the sentinel node draining from the breast, then it will be injected dermally in the upper inner arm along the Biceps 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 either the subareolar plexus, peritumorally (intraparenchymal or dermally), or dermally in the patient's ipsilateral arm dependent upon the contingencies stated above. 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
- Prevention
- 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
- •18-100 years old
- •Not pregnant or breastfeeding
- •Breast cancer requiring lymph node evaluation for the ipsilateral or contralateral breast OR prophylactic mastectomy
- •Willing participation following an informed consent process
排除标准
- •Patient < 18 y/o or > 100 y/o
- •Pregnant or breastfeeding
- •If a pregnant female should be diagnosed with breast cancer an exception would be considered on a case to case basis.
结局指标
主要结局
Occurrence of lymphedema by the first year following surgery
时间窗: One year
An occurrence will consist of an increase of 20% or more in ipsilateral arm volume over the pre-surgery volume, and be accompanied by a confirmatory diagnosis of lymphedema from the UAMS lymphedema clinic.
次要结局
- Successful protection of the arm lymphatics during SLNB and/or ALND.(Time of surgery)
- Occurrence of crossover (i.e., co-localization) between hot breast SLN and blue arm lymphatics.(Time of surgery)
- Characterization of location (typical versus variant) of arm lymphatics.(Time of surgery)
- Successful identification (i.e., localization) of breast SLN and arm lymphatics(Time of surgery)