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A Phase 2a, Single-dose, Open-label Study to Evaluate Diagnostic Performance and Safety of Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer, in Patients With Unknown Primary Head and Neck Cancer (ILLUMINATE STUDY)

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Trial Profile

A Phase 2a, Single-dose, Open-label Study to Evaluate Diagnostic Performance and Safety of Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer, in Patients With Unknown Primary Head and Neck Cancer (ILLUMINATE STUDY)

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 17 Apr 2025

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At a glance

  • Drugs Pegsitacianine (Primary)
  • Indications Head and neck cancer; Squamous cell cancer
  • Focus Adverse reactions; Diagnostic use
  • Acronyms ILLUMINATE

Most Recent Events

  • 03 Apr 2025 Planned number of patients changed from 40 to 120.
  • 23 Apr 2024 Status changed from not yet recruiting to recruiting.
  • 22 Aug 2023 Planned initiation date changed from 1 Jul 2023 to 1 Jul 2024.

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