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，每年总共诊断出192,370例新的浸润性乳腺癌和62,280例新的原位乳腺癌。可手术的乳腺癌患者接受保乳手术（BCS），也称为乳房肿瘤切除术或部分乳房切除术。平均有50%到75%的乳腺癌患者接受BCS后再进行放射治疗。大约20-70%接受BCS的妇女由于第一次BCS的肿瘤切除不完全而不得不再次手术。对于快速实用的术中乳腺肿瘤边缘评估工具的需求尚未得到满足。本次BRP的总体目标是将来自杜克大学和威斯康星大学麦迪逊分校的多名研究人员聚集在一起，共同开发和验证用于BCS患者术中肿瘤边缘成像的微型光谱成像策略。实现这一目标需要在光学物理和工程方面进行重大创新，并将利用薄膜探测器、波导和机载电子技术的进步。建议工作的具体目标是：(1)设计、构建和完善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的性能指标；(3)开发和优化自动化设备-组织接口平台，最大限度地减少设备-组织接口的系统和随机误差来源。(4)在大约150名接受BCS的患者中测试用于检测边缘阳性的微型光谱成像设备。该临床研究将为后续更大规模的临床研究奠定重要基础。理论上，在BRP项目中开发和测试的微型光谱成像系统将成为一种实用的临床工具，用于快速术中评估乳腺肿瘤边缘，也就是说，它将帮助指导外科医生完成手术，如果边缘是阴性的，或者重新切除额外的组织，如果边缘在第一次手术时是阳性的，从而避免不必要的再次切除。这项研究意义重大，因为每年可以避免数万例不必要的手术。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，包括脑癌、前列腺癌和头颈癌。这项新技术也有潜力作为全球癌症诊断的低成本解决方案。

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.