Optical surveillance of tumor margins in patients undergoing breast conserving su

描述（由申请人提供）：2005年，72,000名接受乳房手术的妇女由于第一次手术中肿瘤未完全切除而不得不进行第二次再切除手术。需要第二次手术意味着癌症复发、患者焦虑、并发症和费用增加。目前，外科医生还没有现成的、经济有效的术中器械来确保癌症已经完全切除，以防止再次切除。为了改善护理，外科医生正在寻求肿瘤切除部位边缘的实时信息。先前术中解决方案（冷冻切片和细胞学）以防止再次切除未被采用，因为它们需要在手术室的病理学家，在手术中花费太长时间，只检查不到1%的肿瘤边缘。我们的长期目标是开发一种化学特异性和定量的多通道光学检测装置，用于保乳手术（乳房肿瘤切除术）患者术中肿瘤边缘的评估。该光学装置将对切除标本中约80%的肿瘤边缘进行非破坏性评估（相对于触摸准备或冷冻切片提供的1%）；不需要专门人员或样品处理（切割和染色）；而且比传统技术所需的时间要少得多。这项工作的目标是设计、制造和评估单通道alpha版本的光学检测设备，该设备将提供点测量，并对离体乳腺组织进行试点临床研究，以证明我们的新技术的可行性和有效性。具体目标是：(1)利用蒙特卡罗模拟设计和优化单通道光学器件；(2)在模拟的基础上构建alpha原型装置；(3)在合成乳腺组织幻影上与标准台式光学系统对比验证该装置的性能，并在临床试验中确定该装置在切除的人类乳腺组织标本上的灵敏度和特异性。与此同时，我们正在招聘管理、监管和报销策略方面的专家，以便在研发项目完成后将该设备推向市场。该设备将具有显著的临床益处，包括：(1)减少重复手术，从而减少局部复发；(2)减少组织切除，在第一次手术时转化为更美观的肿瘤切除；(3)减少情绪困扰；(4)减少手术次数和缩短患者恢复时间而减少并发症；(5)降低患者和医疗保健系统的成本。该项目的成功完成将为快速、多像素光学检测系统的开发奠定基础，该系统可用于乳腺癌手术患者术中肿瘤边缘的评估。光学分析系统将具有显著的临床益处，包括：(1)减少再切除率；(2)减少组织切除，在第一次手术时转化为更美观的乳房肿瘤；(3)更好的边缘评估导致减少重复手术，从而减少局部复发；(4)减少情绪困扰；(5)减少手术次数和缩短患者恢复时间而减少并发症。

DESCRIPTION (provided by applicant): In 2005, 72,000 women that underwent breast surgery had to have a second re-excision surgery due to incomplete removal of the cancer during the first surgery. Needing a second surgery means increased cancer recurrence, patient anxiety, complications, and cost. Currently, surgeons have no readily available, cost efficient, intraoperative instruments that ensure that the cancer has been completely excised to prevent re-excision. To improve care, surgeons are seeking real time information on the tumor margins at the site of excision. Prior intraoperative solutions (frozen section and cytology) to prevent re-excision have not been adopted because they required a pathologist in the O.R., take too long during surgery, and only examine less than 1% of the tumor margin. Our long-term objective is to develop a chemically specific and quantitative multi-channel optical assay device for intraoperative assessment of tumor margins in patients undergoing breast conserving surgery (lumpectomy). The optical device will provide non-destructive evaluation of approximately 80% of the tumor margin in the excised specimen (as opposed to 1% provided by touch prep or frozen section); require no specialized personnel or sample processing (cutting and staining); and will require considerably less time than conventional techniques. The goal of the work is to design, fabricate and evaluate a single- channel alpha version of the optical assay device that will provide point measurements, and conduct a pilot clinical study on ex vivo breast tissues to demonstrate the feasibility and effectiveness of our novel technology. The specific aims are to: (1) design and optimize a single-channel optical device using Monte Carlo simulations; (2) build an alpha prototype device based on the simulations, and (3) validate the device's performance against a standard bench- top optical system on synthetic breast tissue phantoms, and determine the sensitivity and specificity on excised human breast tissue specimens in a pilot clinical study. Concurrent with this effort, we are recruiting expertise in management, regulatory and reimbursement strategies so that we will be well positioned to bring this device to market following completion of the R&D program. This device will have significant clinical benefits including: (1) reduced repeat surgeries and hence, reduced local recurrence, (2) reduced tissue removal, which translates to cosmetically-superior lumpectomies at the time of the first surgery, (3) reduced emotional distress, (4) reduced complications due to reduced number of surgeries and shorter recovery times for the patient and (5) reduced cost for the patient and the healthcare system. Successful completion of this project will set the foundation for the development of a fast, multi-pixel optical assay system for intraoperative assessment of tumor margins in patients undergoing breast cancer surgery. The optical assay system will have significant clinical benefits including: (1) reduced re-excision rates, (2) reduced tissue removal, which translates to cosmetically-superior lumpectomies at the time of the first surgery, (3) better margin assessment leading to reduced repeat surgeries and hence, reduced local recurrence, (4) reduced emotional distress, and (5) reduced complications due to reduced number of surgeries and shorter recovery times for the patient.