A Novel Optical Spectral Imaging System for Rapid Imaging of Breast Tumor Margins

描述（由申请人提供）：美国癌症协会估计，每年共诊断出192，370例新发浸润性乳腺癌和62，280例新发原位乳腺癌病例。患有可手术乳腺癌的妇女接受保乳手术（BCS），也称为乳房肿瘤切除术或部分乳房切除术。平均50%至75%的乳腺癌患者接受BCS，然后进行放射治疗。大约20-70%的接受BCS的妇女由于在第一次BCS时癌症切除不完全而不得不返回进行重复手术。对于用于乳房肿瘤边缘的术中评估的快速且实用的工具存在显著未满足的需求。本BRP的广泛目标是将来自杜克大学和威斯康星州大学（麦迪逊）的多名研究者聚集在一起，开发并验证用于BCS患者肿瘤边缘术中成像的微型光谱成像策略。实现这一目标需要光学物理和工程方面的重大创新，并将利用薄膜探测器、波导和机载电子器件的进步。拟议工作的具体目标是：（1）设计、构造和改进用于定量光谱成像的微型光谱成像设备和软件，（2）通过严格的台架测试验证光谱成像技术性能度量，（3）开发和优化自动化设备-组织界面平台，并最小化设备-组织界面处的系统误差和随机误差的来源，以及（4）在大约150名接受BCS的患者中测试用于边缘阳性检测的微型光谱成像设备。拟定的临床研究将作为后续更大规模临床研究的重要基础。理论上，在该BRP赠款中开发和测试的微型光谱成像系统将产生用于快速术中评估乳腺肿瘤边缘的实用临床工具，即，它将帮助指导外科医生在边缘为阴性的情况下完成手术，或者在第一次手术时边缘为阳性的情况下再次切除额外的组织，从而避免不必要的再次切除。其意义重大，因为每年可以防止成千上万的不必要的手术。这项研究中提出的技术也可以扩展到其他类型癌症患者的肿瘤边缘评估，包括脑，前列腺和头颈部。这项新技术也有可能成为全球癌症诊断的低成本解决方案。 公共卫生相关性：我们的长期科学目标是开发和应用一种新的光学策略，用于乳腺肿瘤边缘的术中评估。我们建议开发的技术将被务实地设计和完善，用于术中环境。术中切缘评估工具与公众密切相关，因为它将有助于减少乳腺癌患者的再次切除手术。

DESCRIPTION (provided by applicant): The American Cancer Society estimates that a total of 192,370 new invasive breast cancers and 62,280 new cases of in situ breast cancer are diagnosed annually. Women with operable breast cancer undergo Breast Conserving Surgery (BCS), also called lumpectomy or partial mastectomy. On average between 50 to 75% of patients with breast cancer undergo BCS followed by radiation therapy. Approximately 20-70% of women undergoing BCS have to return for a repeat surgery due to incomplete removal of the cancer at the first BCS. There is a significant unmet need for a rapid and practical tool for intra-operative assessment of breast tumor margins. The broad goal of this BRP is to bring multiple investigators from Duke University and the University of Wisconsin, Madison together to develop and validate a miniature optical spectral imaging strategy for intra- operative imaging of tumor margins in patients undergoing BCS. Achieving this goal requires significant innovation in optical physics and engineering, and will leverage advances in thin film detectors, waveguides, and on-board electronics. The specific aims of the proposed work are: (1) to design, construct and refine a miniature spectral imaging device and software for quantitative optical spectral imaging, (2) to verify the spectral imaging technology performance metrics through rigorous bench testing, (3) to develop and optimize an automated device-tissue interface platform and to minimize sources of systematic and random errors at the device-tissue interface, and (4) to test the miniature spectral imaging device for the detection of margin positivity in approximately 150 patients undergoing BCS. The proposed clinical studies will serve as an important basis for larger scale successor clinical studies. It is theorized that the miniature optical spectral imaging system developed and tested in this BRP grant will result in a practical clinical tool for rapid intra- operative assessment of breast tumor margins, i.e., it will help guide the surgeon to either complete the surgery, if margins are negative, or re-excise additional tissue, if margins are positive at the time of first surgery, thus avoiding an un-necessary re-excision. The implications are significant in that tens of thousands of unnecessary surgeries could be prevented each year. The technology proposed in this research could also be extended to the assessment of tumor margins in patients with other types of cancers, including the brain, prostate and head and neck. This novel technology also has the potential to serve as a low cost solution for global cancer diagnostics. PUBLIC HEALTH RELEVANCE: Our long-term scientific aim is to develop and apply a novel optical strategy for intra-operative assessment of breast tumor margins. The technology we propose to develop will be pragmatically designed and refined for use in an intra-operative setting. A tool for intra-operative margin assessment is significantly relevant to public in that it will contribute to a decrease in re-excision surgeries in patients with breast cancer.