NL-OMON49864已完成不适用
Identification of sentinel lymph nodes in breast cancer patients through non-invasively and percutaneously fluorescent imaging using ICG - INFLUENCE-trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Clinically node-negative, invasive early T1 or T2 breast cancer confirmed by
- •- Preoperative axillary ultrasound to confirm clinical node-negative status.
- •- Indication for lumpectomy and SLN procedure.
- •- Written informed consent according to ICH/GCP and national regulations.
排除标准
- •- Patients < 18 years old.
- •- Mastectomy.
- •- Known allergy for indocyanine green (ICG) or radioisotope technetium (99mTc)
- •or intravenous contrast, iodine, shellfish.
- •- Other concurrent solid tumor.
- •- Hyperthyroidism or thyroid cancer.
- •- Palliative surgery for locally advanced breast cancer (cT4).
- •- Pregnancy or breast feeding.
- •- Psychological, familial, sociological or geographical factors that could
- •potentially hamper compliance with the study protocol.
研究者
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