Development of Parametric Response Mapping Software for Clinical Cancer Response Assessment

在过去的十年里，密歇根大学(UM)的研究人员率先开发了这一技术 弥散加权磁共振成像(DW-MRI)作为脑胶质瘤早期治疗反应生物标志物的研究 肿瘤，首先在动物模型中，然后在人类中。复杂的异类响应模式，通常 在治疗的肿瘤中观察到的，带领UM团队开发了一种基于体素的分析方法 空间非均匀扩散值的量化，称为扩散参数响应图 (PRMADC)。许多实验室已经证实使用DW-MRI对治疗进行早期评估 在各种原发和转移性癌症类型中的反应。然而，到今天为止，它仍然被限制为一种 研究工具。这项前景看好的技术要想进入常规的临床应用，必须进行商业应用 开发并整合到临床工作流程中。在这项赠款努力中，我们建议实现这一目标 通过密歇根大学(UM)和IMBIO，LLC调查人员之间的密切合作。具体来说， 这一合作努力将开发一个临床级别的软件解决方案，该解决方案将执行PRMADC，该解决方案已经 显示为癌症治疗管理提供所需的空间和数量信息 病人。目前的努力将集中在胶质瘤的开发活动上，因为这些数据很容易 可从之前由NIH资助的UM试验中获得。因此，这项快速通道提案的具体目标将制定一个 商业PRMADC软件应用，包括FDA所需的产品测试和数据采集 510(K)应用程序，使用从先前NIH赞助的临床试验中获得的图像和患者信息。 总体而言，预计这项工作的成功结果将为以下方面提供交钥匙软件解决方案 放射科医生对胶质瘤患者的治疗反应进行纵向评估，从而改善患者状况 医疗保健和降低医疗保健系统的成本。重要的是，密歇根大学和英比奥大学的团队 成功的合作记录，已经有一个FDA批准的PRM应用程序用于肺部CT成像 现已在美国、欧洲和加拿大进行商业销售。

Over the last decade, investigators at the University of Michigan (UM) have pioneered the development of diffusion-weighted MRI (DW-MRI) as an early treatment response imaging biomarker in glioma brain tumors, first in animal models and then in humans. Complex heterogeneous response patterns, typically observed in treated tumors, have led the UM team to the development of a voxel-based, analytical approach for quantification of spatially heterogeneous diffusion values referred to as the diffusion Parametric Response Map (PRMADC). Numerous laboratories have validated the use of DW-MRI for early assessment of treatment response in a variety of primary and metastatic cancer types. Nevertheless, as of today it remains confined as a research tool. For this promising technology to enter routine clinical use, a commercial application must be developed and integrated within the clinical workflow. In this grant effort, we propose to achieve this goal through the close partnership between University of Michigan (UM) and Imbio, LLC investigators. Specifically, this collaborative effort will develop a clinical grade software solution that executes PRMADC, which has been shown to provide the needed spatial and quantitative information for treatment management of cancer patients. The current effort will focus development activities for use in glioma as these data are readily available from prior NIH-funded UM trials. Thus the Specific Aims of this Fast-Track proposal will develop a commercial PRMADC software application, including product testing and data acquisition necessary for a FDA 510(k) application using images and patient information obtained from prior NIH-sponsored clinical trials. Overall, it is anticipated that the successful outcome of this effort will provide a turn-key software solution for Radiologists to longitudinally assess treatment response in patients with glioma, leading to improved patient care and a reduction in cost to the healthcare system. Importantly, the teams at UM and Imbio have a very successful track record of collaboration, with already one FDA-cleared PRM application for lung CT imaging which is now available for commercial sale in the USA, Europe and Canada.