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在第一次手术中未完全切除癌症而不得不进行第二次再次切除手术。需要第二次手术意味着增加癌症复发，患者焦虑，并发症和成本。目前，外科医生没有现成的、具有成本效益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，外科医生正在寻找切除部位肿瘤边缘的真实的时间信息。先前用于防止再次切除的术中解决方案（冷冻切片和细胞学）尚未被采用，因为它们需要手术室中的病理学家，手术时间过长，只能检查不到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，用于术中评估接受保乳手术（乳房肿瘤切除术）的患者的肿瘤边缘。光学设备将提供切除标本中约80%的肿瘤边缘的非破坏性评价（而触摸制备或冷冻切片提供的仅为1%）;不需要专业人员或样本处理（切割和染色）;并且所需时间比传统技术少得多。该工作的目标是设计、制造和评估将提供点测量的光学测定设备的单通道α版本，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）使用蒙特卡罗模拟设计和优化单通道光学装置;（2）基于模拟构建α原型装置，以及（3）在合成乳房组织体模上验证装置相对于标准台式光学系统的性能，并在试点临床研究中确定对切除的人类乳房组织样本的灵敏度和特异性。与此同时，我们正在招聘管理、监管和报销策略方面的专业人员，以便在完成研发计划后，我们能够将该设备推向市场。该器械将具有显著的临床受益，包括：（1）减少了重复手术，因此减少了局部复发，（2）减少了组织切除，这在第一次手术时转化为美容上更好的肿块切除术，（3）减少了情绪困扰，（4）由于手术次数减少和患者恢复时间缩短而减少并发症，以及（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开发一种快速、多像素的光学检测系统奠定基础，该系统用于乳腺癌手术患者术中肿瘤边缘的评估。光学测定系统将具有显著的临床益处，包括：（1）减少的再切除率，（2）减少的组织切除，这在第一次手术时转化为美容上优越的肿块切除术，（3）更好的边缘评估导致减少的重复手术，因此减少的局部复发，（4）减少的情绪困扰，以及（5）由于手术次数减少和患者恢复时间缩短而减少了并发症。

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.