Fast and reliable intraoperative tissue diagnosis is a critical component of successful cancer surgery in a variety of organ systems. Yet there continues to exist a significant clinical need for rapid and reliable intraoperative margin assessment of excised surgical specimens. Currently, intraoperative margin assessment is done by visual inspection and palpation, followed by selective assessment of any suspicious areas by rapid histology or cytology evaluation, which can be time consuming and inaccurate due to limited sampling. It is not unusual for the result of this pathologic margin assessment to come after the surgical wound is closed and the patient moved to the recovery room.
Further, there are frequent discrepancies between the selective intraoperative and more comprehensive postoperative pathology margin assessment necessitating reoperation to achieve negative margins. In breastU conserving surgery, for example, reUoperation for positive margins discovered after surgery is required in up to 50% of cases. Furthermore, breast cancer recurs locally in the surgical bed in ~ 10% of patients with negative margins on postoperative pathology margin assessment which, while more comprehensive than intraoperative pathology assessment, is still subject to sampling limitations. Intraoperative assessment of surgical margins is, thus, an important step in surgical management of cancer. Therefore, there is an unmet need to develop rapid and
accurate method to assess breast margins intraoperatively.