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临床试验/NCT04932460
NCT04932460Unknown不适用

A Prospective Multi-center Study: Contrast-enhanced Ultrasonography Combined With Blue Dye as Dual-tracer for Sentinel Lymph Node Biopsy After Neoadjuvant Therapy in Breast Cancer

First Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2021年6月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
350
试验地点
1
主要终点
False negative rate

研究概览

简要总结

False negative rate (FNR) in patients who has accepted neoadjuvant therapy is high. Blue dye and radioisotope as dual-tracer can decrease FNR. Several large clinical trials showed that using dual trace with blue dye and radioisotope can reduce the FNR to less than 10%. But radioisotope is still not approved in China and can cause radiocontamination. A novel dual-tracer which can decrease the FNR in patients after neoadjuvant therapy is urged to be explored. Contrast enhanced ultrasonography (CEUS) can make the lymphatic drainage path and sentinel lymph nodes visible. Retrospective studies found that CEUS can locate SLN precisely. So this clinical trial aim to evaluate FNR, detective rate and numbers of SLN by using CEUS combined with blue dye as dual-tracer in sentinel lymph node biopsy in breast cancer patients after neoadjuvant therapy and the accuracy of CEUS for the diagnosis of lymph node metastasis before and after neoadjuvant therapy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

入选标准

  • ≥18 years old female;
  • ECOG:0 - 1;
  • Biopsy confirmed invasive breast cancer;
  • cT1-4N0-3;
  • Signed informed consent.

排除标准

  • Inflammatory breast cancer;
  • Received ipsilateral axillary surgery previously;
  • During pregnancy.

结局指标

主要结局

False negative rate

时间窗: 6 months

The false negative rate (FNR) of sentinel lymph node biopsy using dual-tracer with CEUS and blue dye after neoadjuvant chemotherapy in invasive breast cancer patients. The FNR is calculated as the number of false negative cases divided by the number of false negative plus true positive cases and then multiplied by 100%.

次要结局

  • The detective rate of sentinel lymph node biopsy(6 months)
  • The average numbers of sentinel lymph node(6 months)
  • The accuracy of CEUS in evaluation of axillary lymph nodes in breast cancer(6 months)

研究者

发起方
First Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ying Lin

Vice Director of Department of Breast Surgery

First Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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