EUCTR2009-016743-18-GB进行中（未招募）1 期
A feasibility study of indocyanine green (ICG) fluorescence mapping for sentinel lymph node detection in early breast cancer - ICG10
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
入选标准
- •- biopsy proven invasive breast cancer in women over 18.
- •- 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.
- •- able to give written informed consent
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- history of previous breast cancer
- •- women unable to provide informed consent
- •- prior axillary surgery or a diagnostic excision biopsy of the breast
- •- pregnant or lactating women
- •- hypersensitivity to indocyanine green or to sodium iodide
- •- hypersensitvity to iodine
- •- patients with hyperthyroidism or patients with toxic thyroid adenomas
- •- unable to give written informed consent
研究者
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