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

具有实时多模态图像引导的周围肺结节活检探头

• 批准号: 9044358
• 负责人: Andrei Vertikov
• 金额: $ 22.43万
• 依托单位: LX MEDICAL CORPORATION
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-05-01 至 2018-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9044358
• 关键词: 3-Dimensional; Address; Animal Model; Behavior; Biological; Biopsy; Blood Vessels; British Columbia; Bronchi; Bronchoscopes; Bronchoscopy; Caliber; Cancer Etiology; Catheters; Cessation of life; Chemicals; Clinical; Collection; Color; Conscious Sedation; Custom; Data Set; Detection; Devices; Diagnosis; Diagnostic; Doppler Effect; Dose; Electromagnetics; Family suidae; Fluorescence Bronchoscopy; Forcep; Future; Goals; Hemorrhage; Human; Image; Image Guided Biopsy; Knowledge; Lesion; Light; Local anesthesia; Location; Lung; Lung nodule; Malignant - descriptor; Malignant Neoplasms; Malignant neoplasm of lung; Medical; Medical Device; Microscope; Miniaturization; Modality; Modeling; Needle biopsy procedure; Needles; Nodule; Optical Coherence Tomography; Patients; Performance; Peripheral; Pharyngeal structure; Phase; Pneumothorax; Positioning Attribute; Preparation; Procedures; Property; Radial; Research; Resolution; Risk; Safety; Sampling; Side; Site; Small Business Innovation Research Grant; Specificity; Spiral Computed Tomography; Spottings; Structure of parenchyma of lung; Survival Rate; System; Techniques; Testing; Three-Dimensional Image; Time; Tissue Sample; Tissues; Translating; Ultrasonography; Work; X-Ray Computed Tomography; animation; base; diagnostic accuracy; follow-up; high risk; image guided; imaging modality; imaging probe; improved; in vivo; innovation; instrument; lung cancer screening; medical specialties; miniaturize; molecular pathology; population based; pressure; primary outcome; programs; public health relevance; sample collection; screening; sound; tool; virtual

 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.

 描述（申请人提供）：最近的技术进步使得低剂量螺旋CT成为肺癌筛查的有效工具，然而，CT引导下经胸发现的大多数肺部结节都很小且难以诊断。针吸活检（CT-TTNB）诊断准确率较高（根据结节大小为 70% 至 90%），但经支气管肺活检发生气胸和出血等并发症的风险较高。使用虚拟支气管镜或电磁导航和内窥镜超声是一种更安全的替代方案，但诊断率通常比 CT-TTNB 低 10% 至 20%。此外，由于非实体肺结节尺寸较大，因此无法通过活检针或导管插入。鞘管用于延长工作通道，以便在取出超声探头后插入活检钳进行活检，而无需实时确认活检部位。因此，临床上对能够取样的安全、准确的活检工具的需求尚未得到满足。该项目的目标是构建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，我们将开发一种结合多普勒的小型光学相干断层扫描 (OCT) 导管。 OCT 与我们将这些 AF/OCT 成像导管与活检工具集成，以便能够从垂直于气道的病变处进行定位和向前采集样本，并与平行于活检的支气管壁进行侧面收集的经支气管活检工具。探针的目标 2 是在猪模型中评估先前目标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，以实现标准和分子病理学诊断以及生物行为的预测。恶性病变。