CT-Bronchoscopy Workstation for Lung-Cancer Assessment

这个第二阶段的SBIR项目是对PAR-01-102“活体成像新技术的开发”的响应。在我们第一阶段可行性工作的基础上，我们建议构建和验证一个完整的工作站--虚拟导航器--用于基于3D MDCT的支气管镜活检计划和指导。肺癌是西方国家最常见的癌症死亡原因，目前5年生存率不到15%。尽管继续 随着技术的进步，肺癌死亡率在1979至1997年间实际上增加了11%。最先进的肺癌诊断和分期程序包括三维(3D)多探测器计算机断层扫描(MDCT)，然后是支气管镜活检。不幸的是，很高比例的活组织检查不成功是因为：(1)缺乏程序规划工具，(2)难以看到活组织检查部位 在支气管镜检查期间，(3)医生技能水平范围广。该项目是由以下假设驱动的：一个基于计算机的系统，能够进行基于3D MDCT的程序规划和后续图像引导的支气管镜检查，可以改进目前肺癌的分期、诊断和治疗程序。具体目标如下。目的1：设计基于多层螺旋CT的程序规划和图像引导支气管镜检查的自动化方法，从而使更有效的活检规划和随后的支气管镜活检成为可能。目标2： 构建用于支气管镜检查的交互式规划和指导的工作站原型，从而为医生提供用于图像引导支气管镜检查的用户友好的系统。目的3：进行人体研究以确定系统的功能，并将该系统与标准实践进行比较。这些研究的重点是可疑纵隔淋巴结和周围结节的支气管镜活检，给出初步的临床评估，并激励后期Ill和FDA 510K测试。由于目前诊断和分期肺癌的技术并不令人满意，因此提供准确的工具来评估肺癌是至关重要的。此外，治疗和治疗的影响在过去20年中基本没有变化。所提出的系统所具有的图像引导方法可以使 准确地将药物直接输送到肺部肿瘤结节或受累淋巴结中。使用虚拟导航仪，可以更好地计划支气管镜检查，可以对更困难的部位进行活检，并减少不成功的活检。这些好处减少了对后续程序的需求，降低了成本，争取了成功治疗的时间，或者，换句话说，改善了肺癌的早期诊断、分期和治疗。

This Phase-II SBIR project is in response to PAR-01-102, "Development of Novel Technologies for In Vivo Imaging." Expanding upon our Phase-I feasibility effort, we propose to construct and validate a complete workstation - the Virtual Navigator- for 3D MDCT-based planning and guidance of bronchoscopic biopsy. Lung cancer is the most common cause of cancer death in the western nations, with the current 5-year survival rate under 15%. Despite continued technological improvements, the lung-cancer mortality rate actually increased 11% between 1979 and 1997. The state-of-the-art procedure for diagnosing and staging lung cancer involves three-dimensional (3D) multi-detector computed-tomography (MDCT) scanning followed by bronchoscopic biopsy. Unfortunately, a high percentage of biopsy procedures are unsuccessful because of the: (1) lack of procedure-planning tools, (2) difficulty in seeing biopsy sites during bronchoscopy, and (3) wide range in physician skill level. The project is driven by the following hypothesis: A computer-based system, enabling 3D MDCT-based procedure planning and follow-on image-guided bronchoscopy, can improve current procedures for the staging, diagnosis, and treatment of lung cancer. The specific aims are as follows. Aim 1: Devise automated methods for MDCT-based procedure planning and image-guided bronchoscopy, thereby enabling more effective biopsy planning and subsequent bronchoscopic biopsy. Aim 2: Prototype a workstation for the interactive planning and guidance of bronchoscopy, thereby providing the physician with a user-friendly system for image-guided bronchoscopy. Aim 3: Perform human studies to establish system functionality and to compare the system to standard practice.These studies, which focus on the bronchoscopic biopsy of suspect mediastinal lymph nodes and peripheral nodules, give a preliminary clinical evaluation and motivate later Phase-Ill and FDA 510K tests. Since the current techniques for diagnosing and staging lung cancer are unsatisfactory, it is critical that accurate tools become available for assessing lung cancer. Further, the impact of therapy and treatment remains largely unchanged over the last twenty years. The image-guided methods featured by the proposed system could make possible the accurate delivery of agents directly into the lung tumor nodule or into involved lymph nodes. With the Virtual Navigator, bronchoscopies can be planned better, more difficult sites can be biopsied, and fewer unsuccessful biopsies will be done. These benefits reduce the need for follow-up procedures, reducing cost and gaining time toward successful treatment, or, stated differently, improve the early diagnosis, staging, and treatment of lung cancer.