Clinical Translation of Deformation Compensation for Image-Guided Liver Surgery

图像引导肝脏手术变形补偿的临床转化

• 批准号: 8200235
• 负责人: WILLIAM Robert JARNAGIN
• 金额: $ 57.03万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-01 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8200235
• 关键词: Abdomen; Accounting; Address; Biological Preservation; Blood Vessels; Clinical; Clinical Trials; Colorectal; Colorectal Neoplasms; Communities; Complex; Computer Simulation; Data; Development; Devices; Disadvantaged; Disease; Disseminated Malignant Neoplasm; Dose; Effectiveness; Environment; Excision; Financial compensation; Frustration; General Population; Goals; Gold; Hepatic; Housing; Image; Image-Guided Surgery; Imagery; Injury to Liver; Intra-abdominal; Investigation; Laparoscopy; Lasers; Lead; Liver; Liver Failure; Liver neoplasms; Liver parenchyma; Magnetic Resonance; Mainstreaming; Malignant neoplasm of liver; Measures; Medical center; Memorial Sloan-Kettering Cancer Center; Metastatic Neoplasm to the Liver; Methodology; Methods; Modeling; Natural regeneration; Nature; Neoplasm Metastasis; Neuronavigation; New York; Operating Rooms; Operative Surgical Procedures; Organ; Outcome; Patient Care; Patients; Phase; Play; Postoperative Period; Procedures; Process; Quantitative Evaluations; Radiation; Reporting; Research; Research Personnel; Residual state; Resolution; Resources; Risk; Role; Scientist; Shapes; Site; Solutions; Staging; Supervision; Support System; Surface; Surgeon; Surgical margins; Survival Rate; System; Techniques; Technology; Testing; Therapeutic; Time; Tissue Model; Tissues; Training; Translations; Ultrasonography; Universities; Update; Work; X-Ray Computed Tomography; base; chemotherapy; clinical research site; cost; efficacy testing; experience; high standard; improved; interest; liver imaging; member; metastatic colorectal; minimally invasive; novel; patient population; research clinical testing; soft tissue; treatment strategy; tumor

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.

描述（由申请人提供）：在某种程度上，使用软组织建模来更新图像引导导航系统还没有被主流科学界所接受。它直到最近才在神经导航社区中得到应用（尽管还没有商业系统可用），目前仍在研究中。这种挫败感大部分不是由于方法论数量的增加，而是由于对模型更新目标的误解，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精细尺度的变形是幼稚的。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？这是本应用程序中要调查的一个中心研究假设。使该应用与众不同的是，如果实现了里程碑，结果可能会导致用于图像引导肝脏手术系统的软组织变形校正系统，该系统可以立即用于患者护理的商业应用。更具体地说，在这项工作的结论中，将产生一个能够变形校正的图像引导肝脏手术系统，将建立这些校正的保真度的初步经验，并且该技术将商业化。这是可能的，因为该应用程序将利用与Pathfinder Therapeutics Incorporated （PTI）的持续关系，该公司正在测试其图像引导肝脏手术（IGLS）系统，并在Memorial Sloan Kettering癌症中心进行独立临床评估。PTI已经同意与PD分享他们的技术平台，并提供开放系统和支持，以支持本文提出的新型组织变形校正策略的集成。PTI团队的成员已经为该应用程序中的方法做出了贡献，并对PD在该应用程序的范围内继续进行科学兴趣。模型可用于校正IGLS内变形的假设将得到三个具体目标的支持，这些目标包括：(1)将非刚性校正计算节点控制器纳入Pathfinder Therapeutics Inc.的指导平台，进行测试，然后部署到我们的临床现场；(2)在临床试验中评估使用计算节点控制器进行术中变形校正；(3)开始在微创手术的背景下研究控制器/系统。之前的工作包括我们的配准方法和变形校正计算节点控制器的开发。我们的努力取得了成功，并显示出了希望。我们准备完成下一阶段的商业化IGLS系统部署，并在两个25例患者的独立临床研究中进行测试，同时解决微创手术。此外，应该注意的是，虽然控制器将集成到特定的平台中，但该技术本身可以与任何图像引导的手术平台集成。