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临床试验/EUCTR2009-011079-57-NL
EUCTR2009-011079-57-NL进行中(未招募)不适用

Evaluation of Indocyanine Green (ICG) enhanced Near-InfraRed Fluorescence (NIRF) Imaging for Intra-Operative Sentinel Lymph Node (SLN) detection in Breast Surgery. - ICG enhanced SLNB

niversity Medical Center Groningen0 个研究点开始时间: 2009年3月20日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)

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

  • Women above 21 years of age with stage I-II breast cancer diagnosed preoperatively by core biopsy or cytology and who have given informed consent according to the rules of the hospital. Patient is undergoing sentinel lymph node mapping for staging and treatment of their disease.
  • 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

  • 1. Refusal of the patient to be included in the study.
  • 2. Pregnant or breast-feeding.
  • 3. History of iodine allergy or anaphylactic reactions to insect bites or medication.
  • 4. Presence or history of hyperthyroidism.
  • 5. Recent surgery on the armpit.
  • 6. Significant renal (serum creatinine = 400 µmol/L) dysfunction.
  • 7. Cardiac and/or pulmonary disease (ASA III-IV).

研究者

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