Biopsy Probes with Real-time Multi-modality Image Guidance for Peripheral Lung Nodules

 描述（申请人提供）：最近的技术进步使低剂量螺旋CT成为肺癌筛查的有效工具。然而，大多数在CT上检测到的肺结节都很小，难以诊断。虽然CT引导下经胸穿刺活检（CT-TTNB）具有较高的诊断准确性（70%至90%，取决于结节大小），但并发症（如气胸和出血）的风险较高。使用虚拟支气管镜或电磁导航和内镜超声进行经支气管肺活检的诊断确认是一种更安全的选择。但诊断率一般比CT-TTNB低10%~ 20%。目前的内窥镜超声受到成像探头的尺寸、空间分辨率以及无法显示病变中的血管的限制。此外，非实性肺结节不能很好地通过超声可视化。由于其大尺寸，超声探头不能通过活检针或导管插入。作为替代，使用引导鞘管来延伸工作通道，以允许在移除超声探头后插入活检钳，从而在不实时确认活检部位的情况下进行活检。因此，对于能够在实时图像引导下对小肺结节进行采样的安全且准确的活检工具存在未满足的临床需求。 该项目的目标是建立和评估图像引导活检工具，以解决这一知识差距。在目标1中，我们将开发一种小型光学相干断层扫描（OCT）导管，该导管将多普勒OCT与自体荧光敏感成像相结合。我们将这些AF/OCT成像导管与活检工具集成，以便从垂直于气道的病变中定位和向前采集样本，并与平行于活检探头的支气管壁中的侧收集经支气管活检工具集成。目的2是在猪模型中评价在前述目的中开发的工具以足够产量收集组织样品以实现恶性病变的生物学行为的标准和分子病理学诊断和预测的可行性和能力。

 DESCRIPTION (provided by applicant): Recent technological advances have enabled low-dose spiral CT to become an effective tool for lung cancer screening. The majority of pulmonary nodules detected on CT, however, are small and difficult to diagnose. While CT-guided transthoracic needle biopsy (CT-TTNB) has high diagnostic accuracy (70% to 90% depending on nodule size), the risk of complications such as pneumothorax and bleeding is high. Diagnostic confirmation by transbronchial lung biopsy using virtual bronchoscopy or electromagnetic navigation and endoscopic ultrasound is a safer alternative. However, the diagnostic yield is generally 10% to 20% lower than CT-TTNB. Current endoscopic ultrasound is limited by the size of the imaging probe, spatial resolution, and its inability to display blood vessels in the lesion. Furthermore, non-solid lung nodules are not well visualized by ultrasound. Owing to its large size, the ultrasound probe cannot be inserted through a biopsy needle or catheter. In lieu of this, a guide sheath is used to extend the working channel to allow insertion of biopsy forceps after removing the ultrasound probe to take a biopsy without-real time confirmation of the biopsy site. Therefore, there is an unmet clinical need for safe and accurate biopsy tools that can sample small pulmonary nodules under real-time image guidance. The goal of this project is to build and evaluate image-guided biopsy tools to address this knowledge gap. In Aim 1, we will develop a small optical coherence tomography (OCT) catheter that combines Doppler OCT with autofluorescence sensitive imaging. We will integrate these AF/OCT imaging catheters with biopsy tools that will enable localization and forward sample collection from lesions perpendicular to the airway as well as with side-collecting transbronchial biopsy tools in the wall of a bronchus parallel to the biopsy probe. Aim 2 is to evaluate, in a swine model, the feasibility and ability of the tools developed in the preceding aim to collect tissue samples with sufficient yield to enable standard and molecular pathology diagnosis and prediction of the biological behavior of malignant lesions.