Increasing the diagnostic yield of low-risk bronchial biopsy in the evaluation of

描述(申请人提供)：肺癌是癌症相关死亡的主要原因，其死亡人数超过乳腺癌、前列腺癌和结肠癌的总和。早期诊断对患者生存至关重要，然而绝大多数肺癌只有在出现症状和癌症扩散时才能被发现，此时患者治愈的机会很小。包括CT和支气管镜在内的宏观成像手段在提高早期发现方面取得了重大进展，但它们并不具备诊断恶性肿瘤所需的特异性。诊断必须在显微镜水平上进行，目前只能通过切除活检来完成。不幸的是，用于取回活检样本的低风险支气管镜技术由于诊断率低而受到阻碍，而且经胸和外科方法具有更高的内在并发症风险。鉴于这些宏观成像平台的假阳性率非常高，必须避免高风险的程序，并极大地提高低风险方法的诊断准确性。在这项建议中，我们的目标是使用新的光学成像工具来局部指导活检部位的选择，以确保诊断质量，从而显著提高低风险支气管活检的诊断率 获得了组织病理学和分子图谱的样本。具体地说，我们将开发和转换偏振敏感光学频域成像(PS-OFDI)系统，以及用于进行呼吸道和周围肺PS-OFDI的新型导管。我们将制定和验证肺癌病理PS-OFDI图像的诊断标准，我们将进行临床研究，以证明活检产量比传统方法有所提高。这项工作将利用马萨诸塞州综合医院和九点医疗公司的研究人员之间的专业知识、资源和持续的合作关系。这一已经形成的战略联盟将共同确保一种强大而强大的新型光学支气管镜检查工具的成功转化和交付，这可能会提高用于评估肺癌的支气管镜活检的诊断效率。

DESCRIPTION (provided by applicant): Lung cancer is the leading cause of cancer related death accounting for more deaths than breast, prostate and colon combined. Early diagnosis is critical to patient survival, however the vast majority of lung malignancies are detected only once symptoms arise and the cancer has spread, at which time patients have little chance of cure. Macroscopic imaging modalities including CT and bronchoscopy have made significant strides in increasing early detection; however they do not have the required specificity to diagnose malignancy. Diagnosis must be made on the microscopic level, which at present can only be accomplished with excisional biopsy. Unfortunately, low-risk bronchoscopic techniques for retrieving biopsy samples are hampered by low diagnostic yields, and trans-thoracic and surgical approaches carry higher intrinsic risk of complications. Given the very high false positive rates of these macroscopic imaging platforms it is imperative that high-risk procedures are avoided and the diagnostic accuracy of lower-risk approaches is greatly improved. In this proposal we aim to dramatically increase the diagnostic yield of low-risk bronchial biopsy using novel optical imaging tools to locally guide biopsy site selection ensuring that diagnostic quality samples are obtained for both histopathology and molecular profiling. Specifically, we will develop and translate polarization-sensitive optical frequency domain imaging (PS-OFDI) systems, and novel catheters for conducting PS-OFDI of the airways and peripheral lung. We will develop and validate diagnostic criteria for evaluating the PS-OFDI images of lung cancer pathology, and we will conduct clinical studies to demonstrate the improvement in biopsy yield over conventional approaches. This work will leverage the expertise, resources and ongoing collaborative ties between investigators at Massachusetts General Hospital and NinePoint Medical. Together the strategic alliance already formed will ensure the successful translation and delivery of a powerful and robust new optical bronchoscopy tool that will likely result in an increase in the diagnostic yield of bronchial biopsy for the assessment of lung cancer.