Post-market Evaluation of LumiSystem: Intraoperative Margin Performance and Clinical Utility (IMPACT) Registry

Lumicell Inc. has developed LumiSystem, a combination product consisting of LUMISIGHT (pegulicianine), an optical imaging agent, and Lumicell Direct Visualization System (DVS), a fluorescence imaging device. U.S. Food and Drug Administration (FDA) approved this combination product on April 17, 2024, for the following indication for use: LUMISIGHT and Lumicell DVS are indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. This registry study aims to enroll patients for whom LumiSystem has been clinically indicated and used commercially. This protocol does not direct patient care. This protocol directs the documentation of information about the care and procedures being provided to patients when using LumiSystem consistent with its approved labeling. This registry study will collect data on the use of LumiSystem in a real-world setting.

• Determine change in margin status after using LumiSystem [Срок оценки: Up to approximately 6 weeks]
• Determine impact to adjuvant radiotherapy treatment after using LumiSystem. [Срок оценки: Up to approximately 9 months]
• Determine impact to surgical intervention after using LumiSystem [Срок оценки: Up to approximately 6 weeks]
• Compare LumiSystem performance against standard of care (SoC) [Срок оценки: Up to approximately 6 weeks]
• Report on healthcare utilization for patients undergoing breast conserving surgery (BCS) with LumiSystem. [Срок оценки: Up to approximately 8 weeks]
• Identification of safety signals. [Срок оценки: 7 days]