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，CT上发现的大多数肺结节都很小，很难诊断。虽然CT引导下经胸针活检(CT-TTNB)具有很高的诊断准确率(根据结节大小的不同，70%到90%)，但并发症的风险很高，如气胸和出血。使用虚拟支气管镜或电磁导航和内窥镜超声通过经支气管镜肺活检确认诊断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大小、空间分辨率以及无法显示病变中的血管的限制。此外，超声对非实性肺结节的显示效果不佳。由于其尺寸较大，超声探头不能通过活检针或导管插入。取而代之的是，使用引导套来延伸工作通道，以允许在移除超声探头之后插入活检钳以进行活组织检查，而无需实时确认活组织检查部位。因此，临床上对安全和准确的活检工具的需求还没有得到满足，这种工具可以在实时图像引导下对微小肺结节进行采样。该项目的目标是建立和评估图像引导的活检工具，以解决这一知识差距。在目标1中，我们将开发一种结合了多普勒OCT和自体荧光敏感成像的小型光学相干断层扫描(OCT)导管。我们将把这些AF/OCT成像导管与活检工具集成在一起，这些工具将能够定位并向前采集垂直于呼吸道的病变的样本，以及与活检探头平行的支气管壁上的侧收集经支气管镜活检工具。目的2是在猪模型中，评估在前一个目的中开发的工具的可行性和能力，以足够的产量收集组织样本，以便能够进行标准的分子病理学诊断和预测恶性病变的生物学行为。

 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.