Axillary Reverse Mapping Using Near-infrared Imaging in Invasive Breast Cancer: Predictors of Nodal Positivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Rate of identification
研究概览
简要总结
The initial standard treatment of breast cancer is surgery. Tumor involvement of lymph nodes is of paramount importance in the subsequent management of this cancer and surgery of invasive breast cancer (BC) involves axillary lymph node dissection (ALND). To preserve arm lymphatic drainage during ALND and avoid the risk of arm lymphedema, mapping the lymphatic drainage by axillary reverse mapping (ARM) has been developed. But oncological safety is uncertain.
The ARM procedure presented here uses indocyanine green (ICG) and fluorescence detection of draining lymphatics. The project aims to train surgeons to the technique and to identify predictive factors for metastatic ARM nodes in invasive BC using tumor and axillary pathological parameters to better select patients who would not require removal of the ARM node in the future
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Adult patients over 18 years of age
- •Preoperative diagnosis of Invasive breast cancer
- •Patient deemed for total mastectomy with axillary lymph node dissection (ALND)
- •Subject capable of giving informed consent and participating in the process of consent
- •Affiliated to the french social security
排除标准
- •Mastectomy without ALND
- •Previous ipsilateral axillary radiotherapy
- •Previous axillary surgery
- •Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery
- •Breastfeeding
- •Allergy to indocyanine green
- •Patients with a known history of reaction to iodine or iodine-containing compounds.
- •No consent
- •Impaired capacity to make informed medical decisions
- •Patient on guardianship
研究组 & 干预措施
Study arm
Subcutaneous injection (1 ml) of the indocyanine green into the ipsilateral upper extremity 10 min before the surgery.
Near Infra-red images acquisition is performed during surgery
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
Rate of identification
时间窗: up to 30 days
To determine the Rate of identification of reverse axillary node using Indocyanine green (ICG) and near-infrared (NIR) imaging in invasive breast cancer that undergo total mastectomy and ALND.
次要结局
未报告次要终点