Intraoperative imaging of breast cancer margins using Polarization Subtraction Te

使用偏振减法 Te 对乳腺癌边缘进行术中成像

• 批准号: 8453324
• 负责人: Shabbir Bakir Bambot
• 金额: $ 28.83万
• 依托单位: LUMAMED, LLC
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-04-15 至 2015-07-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8453324
• 关键词: Address; Adjuvant Therapy; Adopted; Adoption; Affect; Anesthesia procedures; Applications Grants; Beds; Breast; Cancer Etiology; Cancer Patient; Cancerous; Cause of Death; Cessation of life; Characteristics; Clinical; Clinical Research; Consultations; Cosmetics; Data; Devices; Diagnosis; Diagnostic radiologic examination; Distant; Dyes; Evaluation; Excision; FDA approved; Feeling; Fluorescence; Fright; Frozen Sections; Future; Gold; Head and Neck Cancer; Healthcare; Heart Diseases; Hematoxylin and Eosin Staining Method; High-Risk Cancer; Histopathology; Hospitals; Hour; Image; Image Analysis; Imagery; Imaging technology; Infection; Legal patent; Lesion; Light; Lung; Magnetic Resonance Imaging; Mainstreaming; Malignant Neoplasms; Malignant neoplasm of brain; Mammary Neoplasms; Marketing; Mastectomy; Methods; Metric; Microscopic; Morbidity - disease rate; Nature; Newly Diagnosed; Nonionizing Radiation; Normal tissue morphology; Operating Rooms; Operative Surgical Procedures; Optics; Organ; Outcome; Pathologist; Pathology; Patients; Performance; Phase; Pilot Projects; Preoperative Procedure; Procedures; Quality of life; Repeat Surgery; Resolution; Risk; Security; Site; Skin Cancer; Specimen; Stream; Surface; Surgeon; Surgical margins; Survival Rate; Technology; Testing; Time; Tissue Preservation; Tissues; Touch sensation; Training; Treatment Cost; Ultrasonography; Visible Radiation; Woman; base; breast lumpectomy; cancer recurrence; cancer surgery; cancer type; cost; cost effective; design; digital; digital imaging; human subject; imaging modality; improved; in vivo; innovation; intraoperative imaging; malignant breast neoplasm; malignant mouth neoplasm; mortality; prevent; prototype; public health relevance; tool; tumor

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.

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，可在乳房保存手术（BCS）（BCS）中可视化肿瘤边缘，该方法在约60-70％的乳腺癌手术中使用。当前，乳腺肿瘤大约使用术前手术中的MRI或CT等方法。但是，在手术过程中，没有可用的实际工具可以准确定位肿瘤边缘或验证切除的组织肿块的边缘负缘，外科医生必须等待组织病理学结果，这可能需要几天。在10％至60％的BCS病例中，组织病理学在边缘发现了其他肿瘤。这种情况导致伴随更高的治疗成本，更大的发病率，辅助治疗延迟，化妆品效果不佳以及患者对外科医生的信心丧失，并想知道“你为什么不全部呢？” Lumascan基于极化减法成像（PSI），该方法是一种专利的方法，可实时对可见且接近IR荧光的荧光和接近IR荧光以及反射率，并从切除组织的浅层层实时地图像，从而为实用，易于使用设备的BCS外科手术提供了广泛的现场，高分辨率和高对比度指导。广泛的田间成像可以更全面地检查组织表面，高分辨率接近了微观病理学和高对比度，使外科医生无需病理学家的帮助即可评估肿瘤边缘。我们旨在建立Lumascan的临床原型，并在40名代表各种乳腺癌类型的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，外科医生使用Lumascan在手术套件中可视化癌症边缘的能力等于基于最终组织病理学图像的病理学家。