NL-OMON55958招募中不适用
Identification of the sentinel lymph node in breast cancer patients through non-invasively fluorescent imaging using Indocyanine Green: an international multicenter implementation study. - INFLUENCE II study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 447
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, DCIS or invasive breast cancer confirmed by biopsy.
- •- Preoperative axillary ultrasound to confirm clinical node-negative status.
- •- Indication for SLN procedure via axillary excision
- •- Written informed consent according to ICH/GCP and national regulations.
排除标准
- •- Patients < 18 years old.
- •- SN-procedure via mastectomy incision
- •- Combined MARI procedure
- •- History of axillary lymph node dissection
- •- 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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