Clinical Translation of Deformation Compensation for Image-Guided Liver Surgery

描述(申请人提供)：在某种程度上，使用软组织建模来更新图像引导导航系统尚未被主流科学界接受。它最近才在神经导航界找到了应用(尽管还没有商业系统可用)，目前仍在调查中。这种沮丧在很大程度上不是由于方法的数量不断增加，而是因为对模型更新的目标的误解，以及无法进行测试和验证。对于前者，认为建模可以解释所有细微尺度的变形是天真的。然而，需要回答的问题是，在手术切缘的范围内，模型更新是否会显著影响手术切除？这是在这一应用程序中要研究的一个中心研究假设。这项应用的不同之处在于，如果实现了这些里程碑，结果可能会产生一种用于图像引导的肝脏手术系统的软组织变形矫正系统，该系统可以立即商业化用于患者护理。更具体地说，在这项工作结束时，将产生一种能够矫正变形的图像引导肝脏外科系统，将建立关于这些矫正的保真度的初步经验，并且该技术将投入商业使用。这是可能的，因为这一应用程序将利用与探路者治疗公司(PTI)的持续关系，该公司正在测试他们的图像引导肝脏手术(IGLS)系统，以及纪念斯隆·凯特琳癌症中心的独立临床评估器。PTI已经同意与PD共享他们的技术平台，并提供开放的系统和支持，以支持本文提出的新的组织变形矫正策略的集成。PTI团队的成员已经为本申请中的方法学做出了贡献，并赋予了在本申请范围内继续与PD合作的科学兴趣。模型可用于校正IGLS内的变形的假设将得到三个具体目标的支持，其中涉及：(1)将非刚性校正计算节点控制器整合到探路者治疗公司的指导平台中，进行测试，然后部署到我们的临床站点，(2)在临床试验中使用计算节点控制器评估术中变形校正，以及(3)开始在微创程序的背景下研究控制器/系统。以前的工作包括开发我们的配准方法和变形校正计算节点控制器。我们在这一努力中取得了成功，并展示了希望。我们准备完成下一阶段，将其部署到商业上可用的IGLS系统中，并在两个25名患者研究的独立临床地点进行测试，以及解决微创程序。此外，应该注意的是，虽然控制器将集成到特定平台中，但该技术本身可以与任何图像引导手术平台集成。 公共卫生相关性：肝脏内的原发癌和转移癌正变得越来越常见。有重要的证据表明，腹内肝手术可以改善患有转移性疾病的患者的生存时间。目前，由于这一过程的复杂性，患者数量有限。更好的可视化和指导将为外科医生提供更多的信心，并将增加手术候选人的数量，并改善这些患者的预后。如果这一应用成功，它将导致第一个商业上可用的能够矫正软组织变形的图像引导肝脏手术系统。所提出的“变形校正计算节点控制器”将具有更广泛的影响，因为它可以很容易地适应于具有类似数据的其他外科系统。此外，该策略还将与微创手术兼容，前提是可以使用我们已经确定的微创方法获取器官形状的信息。目前，矫正软组织变形的唯一商业手段是使用术中磁共振(IMR)和计算机断层扫描(ICT)。这些系统的费用相当高，需要工作人员，在后一种情况下会受到辐射，而且维护费用可能很高。由于它们的笨重性质，病人的输出量也比传统的手术室少得多。信息和通信技术从20世纪80年代中期开始使用，S和IMR从90年代中期开始使用，然而仍然只有少数几个系统在世界各地使用。虽然这些都是缺点，但应该指出的是，这些系统将不会被放弃，并将继续发展。然而，这些设施极有可能成为最危急病例的转诊中心，而不是作为一项主流技术提供。使用“变形校正计算节点控制器”来增强现有图像引导系统的策略成本非常低，可能与IMR/ICT解决方案一样有效，并且可以移植到任何具有图像引导手术系统的医疗中心。这项申请将在弥补这些稀少的转诊中心与普通民众可获得的种类繁多的当地医疗中心之间的脱节方面发挥重要作用。

DESCRIPTION (provided by applicant): To a degree, the use of soft-tissue modeling for updating image-guided navigational systems has not been embraced by the mainstream scientific community. It has only just recently found application within the neuronavigation community (although no commercial systems are available yet) and is still under investigation. Much of this frustration is not due to the growing number of methodologies but rather to a misunderstanding of the goals of model-updating, and an inability to test and validate. With respect to the former, it is naove to believe that modeling can account for all fine-scale deformations. However, the question to be answered is, within the confines of surgical margin, can model-updating significantly impact surgical resection? This is a central research hypothesis to be investigated within this application. What sets this application apart is that if the milestones are achieved, the outcome could result in a soft-tissue deformation correction system for image- guided liver surgery systems that could be immediately commercially available for patient care. More specifically, at the conclusion of this work, an image-guided liver surgical system capable of deformation correction will be generated, a preliminary experience with the fidelity of those corrections will be established, and the technology will be commercially available. This is possible because this application will leverage an ongoing relationship with Pathfinder Therapeutics Incorporated (PTI) that is in the process of testing their image-guided liver surgery (IGLS) system and an independent clinical evaluator at Memorial Sloan Kettering Cancer Center. PTI has agreed to share their technological platform with the PD as well as provide open systems and support to support the integration of the novel tissue deformation correction strategy proposed herein. Members of the PTI team have already contributed to the methodologies within this application and have vested scientific interest to continue within the scope of this application with the PD. The hypothesis that models can be used to correct for deformation within IGLS will be supported by three specific aims which involve: (1) incorporate the non-rigid correction compute node controller into the Pathfinder Therapeutics Inc. guidance platform, test, and then deploy to our clinical site, (2) evaluate intraoperative deformation correction using the compute node controller in a clinical trial, and (3) begin to investigate the controller/system within the context of minimally invasive procedures. Previous work involved the development of our registration methods and deformation correction compute node controller. We have succeeded in this endeavor and have shown promise. We are poised to complete the next phase with the deployment into a commercially available IGLS system, and the testing at an independent clinical site in two 25 patient studies as well as address minimally invasive procedures. In addition, it should be noted that while the controller will be integrated into a specific platform, the technology itself is amenable to integration with any image-guided surgery platform. PUBLIC HEALTH RELEVANCE: Primary and metastatic cancer within the liver is becoming increasingly common. There is significant evidence that intra-abdominal liver surgery improves survival times for patients afflicted with metastatic disease. Currently the patient population is limited largely due to the complexity of this procedure. Better visualization and guidance would provide surgeons more confidence and would increase the number of surgical candidates and improve the outcome for these patients. If this application is successful, it would lead to the first commercially available image-guided liver surgery system capable of soft-tissue deformation correction. The proposed "deformation correction compute node controller" would have more widespread impact by being readily adaptable to other surgical systems with similar data. In addition, the strategy would also be compatible with minimally invasive surgeries provided that information regarding organ shape can be acquired using the minimally invasive approach we have identified. Currently, the only commercial means to correct for soft-tissue deformation is to use intraoperative magnetic resonance (iMR) and computed tomography (iCT). These systems are of considerable expense, require staff, incur radiation in the latter, and can be costly to maintain. Due to their cumbersome nature, the patient through-put is also considerably less than a conventional operating room. iCT has been available since the mid-1980's and iMR has been available since the mid-1990's, yet there are still only a handful of systems being used throughout the world. While these are disadvantages, it should be noted that these systems will not be dispensed with and will continue to be developed. However, it is highly probable that these facilities will become referral centers for the most critical cases rather than available as a mainstream technology. The strategy of augmenting an existing image- guidance system with a "deformation correction compute node controller" is very low cost, may be as effective as the iMR/iCT solution, and is translatable to any medical center with an image-guided surgery system. This application will play an important role in remedying a disconnection between these sparse referral centers and the vast assortment of local medical centers available to the general population.