Sentinel Node Biopsy Vs Observation After Axillary PET Examination
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,528
- 试验地点
- 1
- 主要终点
- stage 1: negative predictive value
研究概览
简要总结
Several researches have proved that avoiding axillary surgery does not worsen the outcome of breast cancer patients with relatively low risk. Based on the routine axillary imaging evaluation (ultrasound and MR etc.) and latest dedicate lymph node PET (LymphPET), axillary nodal burden can be identified before operation.
Therefore this prospective study are designed to evaluate the negative predictive value of LymphPET and to verify whether sentinel lymph node biopsy can be spared in patients with negative preoperative axillary assessment.
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
- •≥18 years old
- •invasive ductal carcinoma or DCIS proved by core needle biopsy
- •tumor size ≤ 5cm
- •negative preoperative axillary assessment(including body examination, ultrasound and MR examination)
- •patients is accessible for the following axillary surgery and pathological test(including sentinel lymph node biopsy and axillary lymph node dissection)
- •≥18 years old
- •invasive carcinoma proved by core needle biopsy
- •has plan for breast conserving surgery and adjuvant radiation after surgery
- •negative preoperative axillary assessment(including body examination, ultrasound and axillary PET mSUV<0.27)
- •patients is accessible for the follow up
排除标准
- •distant metastases
- •in the procedure of neoadjuvant therapy
- •positive preoperative axillary assessment (including body examination, ultrasound and MR examination)
- •pregnancy or breastfeeding
- •axillary biopsy or axillary surgery before LymphPET
- •suffer from diabetes mellitus and without well control of bloodglucose
- •previous malignancy
- •allergic to tracer of LymphPET
- •distant metastases
- •in the procedure of neoadjuvant therapy
- •positive preoperative axillary assessment (including body examination, ultrasound and PET mSUV≥0.27)
- •pregnancy or breastfeeding
- •axillary biopsy or axillary surgery before LymphPET
- •suffer from diabetes mellitus and without well control of bloodglucose
- •previous malignancy
- •allergic to tracer of LymphPET
结局指标
主要结局
stage 1: negative predictive value
时间窗: 6 months
negative predictive value of LymphPET in breast cancer patients with a negative preoperative axillary assessment
stage 2: D-DFS(distant disease-free survival)
时间窗: 5 years
D-DFS of patients with negative preoperative axillary assessment(including LymphPET and other imaging examination) and for whom axillary surgery is spared
stage 2: LRFS(local-regional free survival)
时间窗: 5 years
LRFS of patients with negative preoperative axillary assessment(including LymphPET and other imaging examination) and for whom axillary surgery is spared
次要结局
- stage 1: false negative rate(6 months)
- stage 2: DFS(disease-free survival)(5 years)
- stage 2: OS(overall survival)(5 years)
- stage 2: adverse events of upper limbs(5 years)
- stage 2: breast self evaluation(5 years)