A Novel Near-IR Fluorescent Porphyrazine to Improve Breast Cancer Surgery Outcomes Through Intraoperative Real Time Assessment of Breast Tumor Margins

The effectiveness or curative surgery for patients wit non--metastatic breast cancer is directly related to the ability to excise tumors with tumor-free (i.e. negative) surgical margins. This determination is made by coating the surface of the speciman with ink, and measuring the distance of the ink from the tumor on paraffin sections. This process currently takes three days or longer, and can lead to frequent false positive or false negative results. Alternative methods of margin evaluation such as frozen-section or touch-imprint cytology are not generally used due to problems with feasibility and accuracy. Since the presence of tumor at or near the margin is strongly correlated with the risk of local tumor recurrence "positive" or "close" surgical margins require re-operation in 10% to 50% of all breast conserving operations. Therefore, there is a tremendous need for novel methods of guiding the breast cancer surgeon intraoperatively using real-time detection of residual tomor deposits in the tumor bed. Accurate real-time margin assessment would also find ready applications on other organ systems.