Development of Parametric Response Mapping Software for Clinical Cancer Response Assessment

开发用于临床癌症反应评估的参数反应图软件

• 批准号: 9767576
• 负责人: Craig J Galban
• 金额: $ 48.07万
• 依托单位: IMBIO, LLC
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2020-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9767576
• 关键词: Algorithms; Animal Model; Brain Neoplasms; Canada; Cancer Patient; Clinical; Clinical Data; Clinical Trials; Collaborations; Complex; Computer software; Data; Data Set; Development; Devices; Diffusion; Disseminated Malignant Neoplasm; Early Diagnosis; Early treatment; Environment; Europe; Evaluation; Funding; Glioblastoma; Glioma; Goals; Grant; Healthcare Systems; Heterogeneity; Hospitals; Human; Image; Laboratories; Lung CAT Scan; Magnetic Resonance Imaging; Malignant Neoplasms; Maps; Measures; Methodology; Michigan; Multicenter Trials; Outcome; Output; Patient Care; Patients; Pattern; Phase; Process; Publishing; Research; Research Personnel; Sales; Site; Summary Reports; System; Technology; Testing; Tumor Volume; United States National Institutes of Health; Universities; Vendor; Work; X-Ray Computed Tomography; base; cancer type; clinical imaging; clinically relevant; commercial application; commercialization; comparative; cost; data acquisition; design; diffusion weighted; imaging biomarker; improved; radiologist; response; software development; tool; treatment response; tumor; user-friendly

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.

在过去的十年中，密歇根大学 (UM) 的研究人员率先开发了 弥散加权 MRI (DW-MRI) 作为神经胶质瘤脑部早期治疗反应成像生物标志物的应用 肿瘤，首先是在动物模型中，然后是在人类中。复杂的异构响应模式，通常 在治疗的肿瘤中观察到的结果导致密歇根大学团队开发了一种基于体素的分析方法 空间异质扩散值的量化，称为扩散参数响应图 （PRMADC）。许多实验室已验证使用 DW-MRI 进行早期治疗评估 对多种原发性和转移性癌症类型的反应。然而，截至今天，它仍然被限制为 研究工具。为了使这项有前途的技术进入常规临床应用，必须进行商业应用 在临床工作流程中开发和集成。在这项拨款工作中，我们建议实现这一目标 通过密歇根大学 (UM) 和 Imbio, LLC 研究人员之间的密切合作。具体来说， 这项合作将开发一个执行 PRMADC 的临床级软件解决方案，该解决方案已 显示可为癌症治疗管理提供所需的空间和定量信息 患者。目前的工作重点是用于神经胶质瘤的开发活动，因为这些数据很容易获得 可从之前 NIH 资助的 UM 试验中获得。因此，该快速通道提案的具体目标将制定一个 商业 PRMADC 软件应用程序，包括 FDA 所需的产品测试和数据采集 510(k) 申请使用从先前 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成果将为以下领域提供交钥匙软件解决方案： 放射科医生纵向评估神经胶质瘤患者的治疗反应，从而改善患者的病情 护理并降低医疗保健系统的成本。重要的是，UM 和 Imbio 的团队拥有非常 成功的合作记录，已获得 FDA 批准的一项肺部 CT 成像 PRM 申请 该产品现已在美国、欧洲和加拿大进行商业销售。