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Pivotal Study of the LUM Imaging System for Assisting Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Patients With Breast Cancer

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Trial Profile

Pivotal Study of the LUM Imaging System for Assisting Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Patients With Breast Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Nov 2024

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At a glance

  • Drugs Pegulicianine acetate (Primary)
  • Indications Ductal carcinoma; Early breast cancer
  • Focus Diagnostic use; Registrational
  • Acronyms INSITE
  • Sponsors Lumicell

Most Recent Events

  • 20 Nov 2024 According to a Lumicell media release, LUMISIGHT (pegulicianine) was granted a permanent Healthcare Common Procedure Coding System (HCPCS) code for Hospital Outpatient Prospective Payment System (OPPS) by the Centers for Medicare & Medicaid Services (CMS).
  • 05 Sep 2024 According to a Lumicell media release, the company received approval for transitional pass-through (TPT) status for LUMISIGHT™ (pegulicianine) under the Medicare hospital outpatient prospective payment system (OPPS) by the Centers for Medicare & Medicaid Services (CMS).
  • 25 Mar 2024 According to a Lumicell media release, the company shared data from this study at the Society of Surgical Oncology Annual Meeting in Atlanta, Georgia, March 20-23, 2024.

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