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

基本信息

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
项目类别：
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

项目摘要

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、经济高效且易于使用的设备，用于在保乳手术 (BCS) 期间可视化肿瘤边缘，这种方法用于约 60-70% 的乳腺癌患者。乳腺癌手术。目前，乳腺肿瘤在术前手术中使用 MRI 或 CT 等方法大致定位。然而，在手术过程中，没有实用的工具可以准确定位肿瘤边缘或验证切除的组织肿块是否具有阴性边缘，外科医生必须等待可能需要几天的组织病理学结果。在 10% 至 60% 的 BCS 病例中，组织病理学在边缘发现了额外的肿瘤。这种情况导致重复手术，伴随着更高的治疗成本、更高的发病率、感染风险、延迟的辅助治疗、糟糕的美容效果以及患者对外科医生失去信心并想知道“为什么你没有得到全部？” LumaScan 基于偏振减影成像 (PSI)，这是一种专利方法，可实时对切除组织表层的可见光和近红外荧光和反射率进行成像，为外科医生提供宽视野、高分辨率和高对比度的图像指导，以进行手术在实用且易于使用的设备中进行 BCS 外科手术。宽视野成像可以对组织表面进行更全面的检查，高分辨率接近显微病理学，并且高对比度允许外科医生无需病理学家的帮助即可评估肿瘤边缘。我们的目标是构建 LumaScan 的临床原型，并在代表多种乳腺癌类型的 40 名受试者的临床研究中对其进行测试。我们进一步旨在表明，外科医生使用 LumaScan 在手术室中可视化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同。