跳至主要内容
临床试验/NCT03442543
NCT03442543Unknown1 期

A Novel Technique for Preoperative Localization of Sentinel Lymph Node in Breast Cancer Patients by Silver Wire Insertion or Liquid Charcoal Injection Guided by CT Lymphography

Mansoura University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年7月2日最近更新:
适应症
干预措施

试验速览

阶段
1 期
入组人数
50
试验地点
2
主要终点
detection of the sentinel lymph node by the novel method & matching between the sentinel lymph node detected by the novel method and the control one

研究概览

简要总结

A question is raised about the possibility of accurate localization of the SLN (sentinel lymph node) detected by CTLG (Computed Tomography Lymphography) which offers a detection rate of 100% in many studies In Oncology center, Mansoura University (OCMU), the surgical oncology unit had a previous experience in using charcoal for localization of non-palpable suspicious breast lesions and it showed promising results in comparison to traditional localization methods In addition, we had another study using silver wire for localization of breast masses before neoadjuvant therapy.

In the study, the investigators will study the usage of both methods as preoperative localization methods for the SLN detected by CT lymphography in breast cancer patients The investigators suppose that this method can offer two main advantages over the traditional SLN intraoperative methods which are; saving operative time needed for the intraoperative procedure as well as solving the problem of the need for complex logistic preparations especially for the usage of radioisotope method.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • node negative early breast cancer

排除标准

  • • Unfit patients for general anaesthesia
  • Previous axillary surgery
  • History of breast surgery or incisional biopsy compromising the breast lymphatic drainage.
  • Known hypersensitivity to the dye
  • Patients with clinically positive or suspicious axilla
  • Pregnant females

研究组 & 干预措施

charcoal

Experimental

干预措施: preoperative localization of SLN detected by CTLG by either methods (Device)

silver wire

Experimental

干预措施: preoperative localization of SLN detected by CTLG by either methods (Device)

结局指标

主要结局

detection of the sentinel lymph node by the novel method & matching between the sentinel lymph node detected by the novel method and the control one

时间窗: one year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Omar Hamdy

Principal investigator, Assistant lecturer of surgical oncology

Mansoura University

研究点 (2)

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