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

描述(申请人提供)：美国癌症协会估计，每年共有192,370例新的浸润性乳腺癌和62,280例新的原位乳腺癌被诊断出来。患有可手术乳腺癌的女性接受保乳手术(BCS)，也称为乳房切除术或部分乳房切除术。平均而言，50%至75%的乳腺癌患者在接受放射治疗后接受BCS。大约20%-70%的接受BCS的女性由于在第一次BCS时肿瘤切除不完全而不得不返回进行第二次手术。对于一种用于术中评估乳腺肿瘤边缘的快速而实用的工具，仍有大量未得到满足的需求。这项BRP的广泛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，开发和验证一种微型光学光谱成像策略，用于接受BCS的患者的术中肿瘤边缘成像。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、波导和车载电子设备的进步。拟议工作的具体目标是：(1)设计、建造和改进用于定量光学光谱成像的微型光谱成像设备和软件，(2)通过严格的平台测试来验证光谱成像技术的性能指标，(3)开发和优化自动化设备-组织界面平台，并将设备-组织界面的系统性和随机误差的来源降至最低，以及(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。拟议的临床研究将作为更大规模后续临床研究的重要基础。据推测，在BRP赠款中开发和测试的微型光学光谱成像系统将产生一个实用的临床工具，用于术中快速评估乳腺肿瘤边缘，即，它将帮助指导外科医生要么完成手术(如果边缘是阴性的)，要么重新切除额外的组织，如果第一次手术的边缘是阳性的，从而避免不必要的再次切除。这一影响意义重大，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评估其他类型癌症患者的肿瘤边缘，包括脑癌、前列腺癌和头颈部癌症。这项新技术还有可能成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.