Selective Sentinella Lymph Node Biopsy With Indocyanine Green in Patients With Breast.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15,000
- 试验地点
- 1
- 主要终点
- Number of Sentinel lymph node detected. Scale of numbers
研究概览
简要总结
The current observational study aims to perform the sentinel lymph node in breast cancer in the usual way with technetium 99 and add a second tracer, indocyanine green. The objective is to evaluate the detection rate of the lymph node with indocyanine green compared to the usual technique.
详细描述
In the operating room 1 ml of indocyaninge grenn will be injectec periareolar . After 5 minutes the lymph node will be detected and extracted. The comparison between the lymph nodes detected with Technetium 99 and indocyanine green will be analysed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >18 years of age with breast cancer who are candidates for sentinel lymph node detection will be included.
- •N0 patients or patients who have undergone target axillary detection with good response
排除标准
- •Lymphadenectomy
结局指标
主要结局
Number of Sentinel lymph node detected. Scale of numbers
时间窗: patients included from 1 January of 2024 til January 1 2029
Number of lymph node detected with Indocyanine green and number of lymph node detected iwth techetium 99. Scale of numbers
次要结局
- Number of possitive lymph nodes(patients included from 1 January of 2024 til January 1 2029)
- surgery time in minutes(patients included from 1 January of 2024 til January 1 2029)
研究者
Sandra Lopez Gordo
Doctor and head of the department of breast cancer unit Sandra Lopez Gordo
Omphis Foundation