Intraoperative imaging of breast cancer margins using Polarization Subtraction Te

描述(由申请人提供)：LumaMed LLC建议开发“LumaScan”，这是一种创新的、具有成本效益的、易于使用的设备，用于在乳房保护手术(BCS)中显示肿瘤边缘，约60%-70%的乳腺癌手术使用这种方法。目前，乳腺肿瘤的大致定位方法是在术前程序中使用MRI或CT等方法。然而，在手术过程中，没有可用的实用工具来准确定位肿瘤边缘或验证切除的组织块是否具有阴性边缘，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，更大的发病率，感染风险，延迟的辅助治疗，糟糕的整容效果，患者对外科医生失去信心，并想知道为什么你没有得到所有的？LumaScan基于偏振减影成像(PSI)，这是一种专利方法，实时成像切除组织表层的可见光和近红外荧光和反射，为外科医生在实用、易于使用的设备中进行BCS手术提供宽视野、高分辨率和高对比度的图像指导。宽视野成像允许对组织表面进行更全面的检查，高分辨率接近于显微病理，高对比度允许外科医生在没有病理学家协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，并在代表各种乳腺癌类型的40名受试者的临床研究中对它们进行测试。我们的进一步目标是表明，外科医生使用LumaScan可视化手术套件中的癌症边缘的能力与病理学家基于最终组织病理学图像的能力相当。

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.