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

一种用于乳腺肿瘤边缘快速成像的新型光谱成像系统

• 批准号: 8645626
• 负责人: Nirmala Ramanujam
• 金额: $ 92.06万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-04-01 至 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8645626
• 关键词: Address; Algorithms; American Cancer Society; Area; Benign; Biophotonics; Brain; Breast-Conserving Surgery; Cancer Diagnostics; Classification; Clinical; Clinical Research; Collection; Computer software; Computers; Data; Detection; Devices; Diffuse; Electronics; Engineering; Excision; Fiber; Film; Goals; Gold; Grant; Head and neck structure; Image; Imaging Device; Imaging technology; In Situ; Intervention; Light; Malignant - descriptor; Malignant Neoplasms; Mammary Gland Parenchyma; Mammary Neoplasms; Maps; Mastectomy; Measurement; Measures; Metric; Molecular; Noise; Operative Surgical Procedures; Optics; Outcome; Pathology; Patients; Performance; Phase; Physics; Positioning Attribute; Postoperative Period; Property; Prostate; Radiation therapy; Recruitment Activity; Repeat Surgery; Reproducibility; Research; Research Personnel; Residual Cancers; Sensitivity and Specificity; Signal Transduction; Silicon; Solutions; Source; Specimen; Speed; Surface; Surgeon; System; Techniques; Technology; Testing; Time; Tissue Extracts; Tissues; Translating; Universities; Unnecessary Surgery; Validation; Wisconsin; Woman; Work; base; breast cancer diagnosis; breast lumpectomy; cancer type; cost; design; design and construction; detector; experience; imaging probe; innovation; malignant breast neoplasm; millisecond; new technology; novel; operation; predictive modeling; prevent; public health relevance; research clinical testing; technology development; tissue phantom; tool; tumor

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.

描述（由申请人提供）：美国癌症协会估计，每年诊断出192,370种新的侵入性乳腺癌和62,280例现场乳腺癌病例。患有乳腺癌的妇女接受乳房保存手术（BCS），也称为乳房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。由于不完全去除癌症，大约有20-70％的接受BC的妇女必须进行重复手术。对于乳腺肿瘤边缘的术中评估，需要快速且实用的工具，这很大程度上没有满足。该BRP的广泛目标是将杜克大学和威斯康星大学麦迪逊分校的多个研究人员一起开发和验证一种微型光谱成像策略，以在BCS患者中对肿瘤缘的肿瘤缘进行术中成像。实现这一目标需要在光学物理和工程上进行大量创新，并将利用薄膜探测器，波导和板载电子产品的进步。 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在大约150名接受BCS的患者中，用于检测边缘阳性的微型光谱成像装置。拟议的临床研究将成为大规模继任临床研究的重要基础。理论上认为，在此BRP赠款中开发和测试的微型光谱成像系统将导致一种实用的临床工具，用于快速对乳腺肿瘤边缘进行快速的乳腺内部评估，即，如果边缘是负面的，或者在额外的组织中，它将避免进行额外的疗程，从而有助于指导外科医生完成手术，或者是重新进行额外的疗程。这种影响很大，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对其他类型的癌症患者（包括大脑，前列腺和头颈）患者的肿瘤边缘的评估。这项新型技术还有可能作为全球癌症诊断的低成本解决方案。 公共卫生相关性：我们的长期科学目的是制定和应用新颖的光学策略，以对乳腺肿瘤边缘进行术中评估。我们建议开发的技术将是务实设计和完善的，用于在术中环境中。术中边缘评估的一种工具与公众显着相关，因为它将导致乳腺癌患者重新测试手术的减少。