NL-OMON33334已完成3 期
Evaluation of Indocyanine Green (ICG) enhanced Near-InfraRed Fluorescence (NIRF) Imaging for Intra-Operative Sentinel Lymph Node (SLN) detection in Breast Surgery. - Sentinel node detection with ICG enhanced NIRF optical imaging.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Women above the age of 21 who have biopsy-proven breast cancer stage I-II, and who are undergoing sentinel lymph node mapping for staging and treatment of their disease.
排除标准
- •Pregnant women, hyperthyroidism, significant renal (serum creatinin >= 400 µmol/L), cardiac or pulmonary disease (ASA III-IV), history of iodine allergy or analfylactic reaction to insect bites or medication.
研究者
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Evaluation of Indocyanine Green (ICG) enhanced Near-InfraRed Fluorescence (NIRF) Imaging for Intra-Operative Sentinel Lymph Node (SLN) detection in Breast Surgery. - ICG enhanced SLNBWomen above the age of 21 with core biopsy or cytology proven breast cancer stage I and II, eligible for lumpectomy and sentinel lymph node procedureMedDRA version: 9.1Level: LLTClassification code 10006194Term: Breast cancer NOS stage IMedDRA version: 9.1Level: LLTClassification code 10006195Term: Breast cancer NOS stage IIEUCTR2009-011079-57-NLniversity Medical Center Groningen
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