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临床试验/EUCTR2012-005788-28-AT
EUCTR2012-005788-28-AT进行中(未招募)不适用

Influence of Body Mass Index on the identification rate of indocyanine green (ICG) fluorescence mapping for sentinel lymph node detection in early breast cancer - ICG Study

andeskrankenhaus Fedkirch0 个研究点开始时间: 2013年12月30日最近更新:
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • -biopsy proven invasive breast cancer in women of any age over 18 years of age
  • -tumours measuring < 5cm in maximum diameter radiologically (mammography, ultrasound or MRI)
  • -no evidence of pathological axillary lymph nodes clinically or on ultrasound scan.
  • -SLNB recommended as part of their surgical management for breast cancer
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 50
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 10

排除标准

  • women unable to provide informed consent
  • - history of previous breast cancer
  • - prior axillary surgery or breast excision biopsy
  • - prior axillary surgery or a diagnostic excision biopsy of the breast
  • - pregnant or lactating women
  • - hypersensitivity to indocyanine green (ICG) or to sodium iodide
  • - hypersensitivity to iodine
  • - patients with hyperthyroidism or toxic thyroid adenomas

研究者

发起方
andeskrankenhaus Fedkirch

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