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
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