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临床试验/NL-OMON55958
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

Sint Antonius Ziekenhuis0 个研究点目标入组 447 人开始时间: 待定最近更新:
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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