ICG vs Blue Patent as a Tracer in the Performance of TAD in Patients With cN1 Breast Carcinoma After Neoadjuvant Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Detection rate of sentinel lymph node between tracers
研究概览
简要总结
To validate the use of ICG as a tracer during TAD in patients with cN1 breast carcinoma after neoadjuvant chemotherapy.
详细描述
This patient registry is designed to prospectively collect standardized clinical, imaging, surgical, and pathological data from patients with cN1 breast carcinoma undergoing targeted axillary dissection (TAD) following neoadjuvant chemotherapy, using indocyanine green (ICG) as a lymphatic tracer.
To ensure data quality and consistency the following procedures and quality control measures will be implemented:
Standardized Case Report Forms (CRFs):
All data will be recorded using electronic CRFs developed specifically for the registry. These forms are structured to capture relevant demographic, clinical, radiological, surgical, and pathological variables, including tracer detection rates, number of retrieved nodes, false-negative rates, and complications.
Center Training and Accreditation:
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer cN+ patients who undergo neadjuvant treatment.
排除标准
- •Patients in whom there is a contraindication for the use of ICG.
- •Patients in whom there is evidence of progression of the disease after neoadjuvant treatment.
结局指标
主要结局
Detection rate of sentinel lymph node between tracers
时间窗: 2 years
Compare the detection rate of sentinel lymph node between ICG and blue patent in cN+ patients after neoadjuvant treatment
次要结局
- Adverse effects(2 years)
- Detection rate of SLNB with ICG versus Tc99(2 years)
研究者
Amparo Garcia-Tejedor
Principal Investigator
Hospital Universitari de Bellvitge