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A Phase 2, Single-Dose, Open-Label Study to Evaluate the Diagnostic Performance and Safety of Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Peritoneal Metastases, in Patients Undergoing Cytoreductive Surgery

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Trial Profile

A Phase 2, Single-Dose, Open-Label Study to Evaluate the Diagnostic Performance and Safety of Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Peritoneal Metastases, in Patients Undergoing Cytoreductive Surgery

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 27 Jun 2024

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At a glance

  • Drugs Pegsitacianine (Primary)
  • Indications Appendiceal cancer; Cancer metastases; Carcinoma; Colorectal cancer; Endometrial cancer; Mesothelioma; Ovarian cancer; Pancreatic cancer; Peritoneal cancer
  • Focus Diagnostic use
  • Sponsors OncoNano Medicine

    • Most Recent Events

    • 01 Jul 2024 Results of this study presented in the Annals of Surgical Oncology
    • 06 Jun 2023 Status changed to completed, according to results presented at the 59th Annual Meeting of the American Society of Clinical Oncology
    • 06 Jun 2023 According to results presented at the 59th Annual Meeting of the American Society of Clinical Oncology, Pegsitacianine received Breakthrough Therapy Designation from the U.S. Food and Drug Administration as a result of data collected in this trial.

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