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Single Arm, Prospective, Open Label, Multicenter Study Assessing the Safety and Effectiveness of IC2000 and SPY Fluorescence Imaging Systems in the Visualization of Lymphatic Vessels and Lymph Nodes During Lymphatic Mapping and Sentinel Lymph Node Biopsy in Subjects With Breast Cancer

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Single Arm, Prospective, Open Label, Multicenter Study Assessing the Safety and Effectiveness of IC2000 and SPY Fluorescence Imaging Systems in the Visualization of Lymphatic Vessels and Lymph Nodes During Lymphatic Mapping and Sentinel Lymph Node Biopsy in Subjects With Breast Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Sep 2023

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At a glance

  • Drugs Indocyanine green (Primary)
  • Indications Carcinoma; Ductal carcinoma; Early breast cancer
  • Focus Diagnostic use; Registrational
  • Acronyms FILM-B
  • Sponsors Novadaq Technologies; Stryker Corporation

    • Most Recent Events

    • 17 Aug 2021 Status changed from recruiting to completed.
    • 08 May 2020 Planned End Date changed from 1 Jul 2020 to 1 Dec 2020.
    • 08 May 2020 Planned primary completion date changed from 1 Apr 2020 to 1 Sep 2020.

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