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临床试验/NCT04274946
NCT04274946Unknown不适用

The Comparative Analysis of Multimodal Markers to Identify Sentinel Lymph Node in Breast Cancer

Bulent Ecevit University2 个研究点 分布在 2 个国家目标入组 120 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
2
主要终点
Identification rate of sentinel lymph node

研究概览

简要总结

Sentinel lymph node (SLN) biopsy is the gold standard method to stage axilla in breast cancer. The aim of the study is to compare the efficiency of various methods to identify SLN is breast cancer patients.

详细描述

Various markers has been used for SLN biopsy including isosulfan blue (patent blue), indocyanine green (ICG), radioisotope colloid (RAIC) and ultrasound (US) with several advantages and disadvantages. In this study investigators designed an algorithm using the combination of mapping with patent blue, ICG, RAIC and US to compare the accurate identification of SLN in breast cancer patients. The protocol is based on the hypothesis that identification rate of SLN is increased with multiple agents. Patent blue and ICG provides visual guidance. The combination of dyes with sonographic and RAIC method have the potential to prevent obstacles and ensure better outcomes as an identification strategy.

Patent blue provides visual identification of the SLN. ICG fluorescence can be detected percutaneously and by means of fluorescence imaging system in real time. RAI has several advantages, but disadvantages as well, like cost and invisibility. RAI can only be detected and confirmed by means of sound and numerical value through gamma probe. All breast cancer patients underwent axillary ultrasound before SLNB with different mapping combinations. The determination of abnormal axillary lymph node was followed by ultrasound-guided FNA cytology of these nodes. The sonographic abnormality criteria of the nodes were defined as; completely hypoechoic node, asymmetric focal hypoechoic node, cortical lobulation more than 3, cortical thickness >2mm, totally spheric appearance, absence of fatty hilum and compromise of normal vascularity (hypervascularization from various poles). Patients with negative results of FNA would undergo SLNB. Lymphatic mapping was performed with abovementioned dyes and radioactive colloid. Before the incising for SLNB real time intraoperative US was performed and suspicious axillary lymph nodes were seen by ultrasound guidance. In the SLNB operation, radioactive or dyed nodes and sonographically suspicious nodes were removed and labeled separately for pathological examination.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Histologically confirmed primary breast cancer by core needle, incisional or excisional biopsy
  • cN0 patients
  • In patients with abnormal axillary lymph nodes sonographically US-guided FNA cytology of these nodes were performed and FNA cytology negative patients planed to undergo SLNB with different mapping techniques.

排除标准

  • Patients with neoadjuvant therapy
  • Patients with pathological diagnosed ductal carcinoma in situ by excisional biopsy
  • Patients with pathologically proven axillary disease
  • Patients with T4d tumor

结局指标

主要结局

Identification rate of sentinel lymph node

时间窗: During operation

The ability to identify a sentinel lymph node successfully with different mapping techniques

次要结局

  • False-negative rate of axillary US(Histological report expected within an average of 2 weeks after sentinel lymph node biopsy)
  • Average number of excised sentinel lymph nodes(Histological report expected within an average of 2 weeks after sentinel lymph node biopsy)
  • Morbidity(36 months)

研究者

发起方
Bulent Ecevit University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guldeniz Karadeniz Cakmak

Head of General Surgery Departmet

Bulent Ecevit University

研究点 (2)

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