Intraoperative imaging of breast cancer margins using Polarization Subtraction Te

描述（由申请人提供）：LumaMed LLC提议开发“LumaScan”，这是一种创新的、具有成本效益且易于使用的设备，用于在保乳手术（BCS）期间可视化肿瘤边缘，该方法用于约60-70%的乳腺癌手术。目前，在术前程序中使用诸如MRI或CT的方法来大致定位乳腺肿瘤。然而，在手术过程中，没有实用的工具可以准确地定位肿瘤边缘或验证切除的组织肿块具有阴性边缘，并且外科医生必须等待组织病理学结果，这可能需要几天时间。在10%至60%的BCS病例中，组织病理学发现边缘有额外的肿瘤。这种情况导致重复手术，伴随着更高的治疗费用，更高的发病率，感染风险，延迟辅助治疗，不良的美容效果和患者对外科医生失去信心，并想知道“为什么你没有得到这一切？“LumaScan基于偏振减影成像（PSI），这是一种获得专利的方法，可对切除组织表层的可见光和近红外荧光和反射率进行真实的实时成像，为外科医生提供宽视野、高分辨率和高对比度的图像指导，从而在实用、易于使用的设备中进行BCS外科手术。宽视野成像允许对组织表面进行更全面的检查，高分辨率接近显微病理学，高对比度允许外科医生在没有病理学家帮助的情况下评估肿瘤边缘。我们的目标是建立LumaScan的临床原型，并在代表广泛乳腺癌类型的40名受试者的临床研究中对其进行测试。我们进一步的目的是表明，外科医生的能力，可视化癌症边缘在手术室使用LumaScan是等于病理学家的基础上，最终的组织病理学图像。

DESCRIPTION (provided by applicant): LumaMed LLC proposes developing "LumaScan", an innovative, cost effective and easy to use device for visualizing tumor margins during Breast Conservation Surgery (BCS), a method that is used in about 60-70% percent of breast cancer surgeries. Currently, breast tumors are approximately located using methods such as MRI or CT in a preoperative procedure. During surgery, however, there are no practical tools available that can accurately locate tumor margins or verify that the excised tissue lump has negative margins and the surgeon has to wait for histopathology results which can take several days. In 10 to 60% of BCS cases histopathology finds additional tumor at the margin. This situation results in repeat surgeries with the accompanied higher treatment cost, greater morbidity, infection risk, delayed adjuvant therapy, poor cosmetic outcomes and a patient's loss of confidence in the surgeon and wondering "why didn't you get it all?" LumaScan is based on Polarization Subtraction Imaging (PSI), a patented method that images the visible and near IR fluorescence and reflectance from superficial layers of the excised tissue in real time providing wide field, high resolution, and high contrast image guidance to the surgeon conducting a BCS surgical procedure in a practical, easy to use device. The wide field imaging allows a more comprehensive examination of the tissue surface, the high resolution approaches that of microscopic pathology and the high contrast permits the surgeon to assess tumor margins without the assistance of a pathologist. We aim to build clinical prototypes of LumaScan and test them in a clinical study of 40 subjects representing a wide range of breast cancer types. We further aim to show that the surgeon's ability to visualize cancer margins in the surgical suite using LumaScan is equal to that of a pathologist based on final histopathology images.