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

提高低风险支气管活检评估的诊断率

• 批准号: 8654306
• 负责人: Brett E Bouma
• 金额: $ 52.95万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-04-19 至 2018-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8654306
• 关键词: Accounting; Biopsy; Biopsy Specimen; Breast; Bronchoscopes; Bronchoscopy; Cancer Etiology; Catheters; Cessation of life; Chest; Clinical Research; Colon; Desmoplastic; Detection; Development; Diagnosis; Diagnostic; Early Diagnosis; Early Intervention; Enrollment; Ensure; Evaluation; Excision biopsy; Fibrosis; General Hospitals; Goals; Histopathology; Image; Image Guided Biopsy; Imaging Device; Imaging Techniques; Lasers; Lead; Lesion; Libraries; Lung; Malignant Neoplasms; Malignant neoplasm of lung; Massachusetts; Medical; Microscopic; Microscopy; Molecular Analysis; Molecular Profiling; Morbidity - disease rate; Operative Surgical Procedures; Optics; Pathologist; Pathology; Patients; Peripheral; Physicians; Procedures; Prostate; Pulmonary Coin Lesion; Research Design; Research Personnel; Resources; Risk; Safety; Sampling; Sheep; Site; Specificity; Specimen; Symptoms; System; Techniques; Testing; Time; Tissues; Training; Translating; Translations; Tumor Tissue; Work; X-Ray Computed Tomography; arm; design; design and construction; diagnostic accuracy; high risk; imaging modality; improved; in vivo; mortality; novel; optical frequency domain imaging; optical imaging; preclinical study; prototype; public health relevance; screening; tool; translational study; tumor

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.

描述（由申请人提供）：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。早期诊断对于患者的生存至关重要，然而，绝大多数肺部恶性肿瘤只有在症状出现且癌症扩散时才被发现，此时患者治愈的机会很小。包括 CT 和支气管镜检查在内的宏观成像方式在提高早期发现方面取得了重大进展；然而，它们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，用于检索活检样本的低风险支气管镜技术受到低诊断率的阻碍，并且经胸和手术方法具有较高的并发症内在风险。鉴于这些宏观成像平台的误报率非常高，必须避免高风险程序，并大大提高低风险方法的诊断准确性。在本提案中，我们的目标是使用新型光学成像工具显着提高低风险支气管活检的诊断率，以局部指导活检部位选择，确保诊断质量 获得样品用于组织病理学和分子分析。具体来说，我们将开发和转化偏振敏感光频域成像（PS-OFDI）系统，以及用于对气道和周围肺进行 PS-OFDI 的新型导管。我们将制定并验证评估肺癌病理学 PS-OFDI 图像的诊断标准，并且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总医院和 NinePoint Medical 的研究人员之间的专业知识、资源和持续的合作关系。已经形成的战略联盟将确保成功转化和交付强大而强大的新型光学支气管镜工具，这可能会提高用于评估肺癌的支气管活检的诊断率。