High Resolution Optical Coherence Tomography for Early Airway Cancer Detection

描述(申请人提供)：背景：肺癌是美国癌症死亡的主要原因。新型高分辨率内窥镜的发展对于更准确地诊断、分期和治疗支气管腔内恶性肿瘤至关重要。在快速获取高分辨率柔性光纤和刚性探头光学相干断层扫描(OCT)方面的最新进展为内窥镜实时近组织水平光学成像提供了潜在的可能性，从而大大改进了对气道癌的检测、诊断和治疗方法。内窥镜OCT在呼吸道诊断和治疗中的应用将是一个重大进步，它需要：1)开发二维和三维MEMS内窥镜探头，2)改进采集时间、分辨率和对比度，3)硬件和技术优化的翻译临床前研究，4)临床患者研究，以展示OCT检测呼吸道癌症的能力和有效性。这项资助计划侧重于推动针对特定肺癌应用的实时高分辨率OCT技术的开发和临床研究，在这些应用中，对灵活和严格的高分辨率光学内窥镜的需求是明确的：1)评估和评估支气管内癌边缘，以及2)评估改进的支气管内癌检测的可行性。目的和目的：本研究方案的总体目标是开发高分辨率三维功能性OCT(F-OCT)内窥镜，并评估其在患者呼吸道早期癌症检测和评估中的能力。具体目标是：1)进一步开发用于硬性支气管镜检查的i)小直径(1 Mm)光纤、MEMS和ii)内窥镜三维栅格OCT探头。刚性探头还可用于胸腔镜检查和其他内窥镜检查应用)。2)将F-OCT技术应用于肺癌的诊断，确定OCT对气道癌诊断的敏感性和特异性。3)在临床研究中结合OCT和荧光内窥镜技术来检测支气管镜下的呼吸道肿瘤，与组织学研究相比具有更高的诊断特异性设计：用于检测呼吸道恶性肿瘤边缘和早期气道癌的柔性光纤和刚性内窥镜探头原型将在临床前研究中优化用于支气管镜和内窥镜成像应用，然后在临床研究中检测可疑呼吸道恶性肿瘤患者的癌症。相关性：该项目将开发全功能实时近显微分辨率的呼吸道成像方法，并展示它们在改善患者早期气道癌诊断方面的有效性。这种将新的工程成像思想延伸到治疗中也应该能够实现一系列其他肺和非肺内窥镜成像应用

DESCRIPTION (PROVIDED BY APPLICANT): Background: Lung cancer is the leading cause of cancer death in the US. Development of novel high resolution endoscopy is essential for more accurate diagnosis, staging, and treatment of endobronchial malignancy. Recent advances in rapid acquisition high-resolution flexible fiberoptic and rigid probe optical coherence tomography (OCT) offer the potential for endoscopic real-time near histologic level optical maging to substantially advance detection, diagnostics, and treatment approaches to airway cancer. Adaptation of endoscopic OCT to airway diagnostics and therapeutics will be a major advance that requires: 1) development of 2 and 3 dimensional MEMS endoscopic probes, 2) improved acquisition times, resolution, and contrast, and 3) translational pre-clinical studies for hardware and technique optimization, and 4) clinical patient studies for demonstration of capabilities and validation of OCT for airway cancer detection. This grant proposal focuses on advancing development and clinical investigation of real-time high- resolution endoscopic OCT technology directed at specific lung cancer applications where the need for flexible and rigid high-resolution optical endoscopy is well-defined: 1) evaluation and assessment of endobronchial cancer margins, and 2) assessment of improved endobronchial cancer detection feasibility. Objectives and Aims: The overall objectives of this research proposal are to develop high resolution 3- dimensional functional OCT (F-OCT) endoscopy and evaluate its capabilities for airway early cancer detection and assessment in patients. The Specific Aims are: 1) Further the development of i) small diameter (1mm) fiberoptic, MEMS, and ii) endoscopic 3-D grid OCT probes for rigid bronchoscopy. The rigid probes will also be usable for thoracoscopy and other endoscopy applications). 2) Translate F-OCT technology to diagnosis of lung cancer and to determine OCT sensitivity and specificity capabilities for airway cancer diagnosis. 3) Combine OCT with fluorescence endoscopic technologies in clinical studies to detect bronchoscopic airway tumor with high diagnostic specificity compared to histology Study Design: Flexible fiberoptic and rigid endoscopic probe prototypes for detecting airway malignancy margins and early airway cancers will be optimized for bronchoscopic and endoscopic imaging applications in pre clinical studies, then in clinical studies to detect cancer in patients with suspected airway malignancy. Relevance: This project will develop fully functional real-time near microscopic resolution airway imaging methods and demonstrate their effectiveness in improving early airway cancer diagnosis in patients. This extension of novel engineering imaging ideas to the treatment should also enable a range of other pulmonary and non-pulmonary scope imaging applications