Product Development of a Brain Tumor Perfusion Imaging Technology

描述（由申请人提供）：此第二阶段SBIR提案的目标是在第一阶段开始的研究和开发工作的基础上扩展新的增强功能和产品供应，同时还采取初步措施，将公司定位为计划用于第三阶段的多中心临床试验。第一阶段的努力导致了该公司的第一个产品IB NeuroTM 1.0的开发和商业化，该产品获得了FDA 510K的批准，用于脑肿瘤和中风的适应症。该产品使用灌注分析算法，在脑肿瘤患者中进行的多年比较研究中，该算法被证明是最稳健的。该产品的一个关键要素是泄漏校正算法，这对于准确评估脑肿瘤至关重要。目前，没有其他获得FDA许可的灌注分析软件产品包含泄漏校正算法。因此，IB Neuro 1.0产品首次提供了先进且经过验证的算法，用于以强大且易于使用的方式分析MRI灌注数据。 鉴于这一早期的成功，该II期提案的具体目标是以三种重要方式扩展IB NeuroTM的功能。首先，将添加额外的工具，以比较研究间的成像数据。这种能力对于最有效和准确地评估标准治疗（如化疗和放疗）以及靶向肿瘤新血管生长（血管生成）的新可用和有前途的生物制剂尤为重要。其次，该公司的专利双回波灌注技术将作为IB Neuro 1.1的一部分进行开发。通过这种专有技术，可以同时收集DSC（动态磁化率对比）和DCE（动态对比增强）灌注数据，同时仅使用单剂量的造影剂。IB神经1.1.将结合工具来生成相关的灌注参数，包括CBV（脑血容量），CBF（脑血流量）以及Ktranss，血管渗透性的标志物。第三个目标是整合必要的功能，以更具体地支持用于卒中评价的灌注数据评价。这些产品开发目标中的每一个都将在收到公司重要网站的频繁反馈的情况下完成。这将使公司能够进行计划的III期多中心试验。 总体而言，IB的技术利基是开发插入现有供应商系统的先进成像分析工具，这将使先进的成像选择能够以具有成本效益的方式更广泛地提供给诊所和患者。其结果将是在更广泛的基础上提供最好和最先进的病人护理。这有可能改变目前关于如何计划和监测治疗的临床实践范例，因为这些经过验证的先进技术中没有一种以前广泛使用。 公共卫生相关性：该第二阶段SBIR提案的目标是使公司Imaging Biometrics LLC能够继续开发和分销用于评估脑肿瘤和中风的创新和成熟的灌注和扩散分析软件。虽然有独立的选项，但主要的方法是开发插入现有供应商系统的软件。通过这种方法，可以在广泛和具有成本效益的基础上提供最好和最新的图像分析软件，这有可能改变目前治疗计划和监测的临床实践模式。

DESCRIPTION (provided by applicant): The goal of this Phase II SBIR proposal is to expand upon the research and development efforts, begun in Phase I, with new enhancements and product offerings, while also taking the initial steps to position the Company for a multi-center clinical trial, planned for Phase III. Phase I efforts have led to the development and commercialization of the Company's first product, IB NeuroTM 1.0, which received FDA 510K clearance for indications of brain tumors and stroke. This product uses perfusion analysis algorithms, which were proven to be the most robust in a multi-year comparison study performed in patients with brain tumors. A key element of the product is the leakage correction algorithms, critical for the accurate evaluation of brain tumors. Currently no other perfusion analysis software product with FDA clearance incorporates leakage correction algorithms. Therefore, the IB Neuro 1.0 product makes available, for the first time, advanced and proven algorithms for the analysis of MRI perfusion data in a robust and easy-to-use fashion. Given this early success, the specific objectives of this Phase II proposal are to extend the functionality of IB NeuroTM in three important ways. First, additional tools will be added to enable comparison of imaging data across studies. This capability is especially important for the most efficient and accurate evaluation of both standard treatments (such as chemotherapy and radiation therapy) and for the newly available and promising biologic agents that target a tumor's new blood vessel growth (angiogenesis). Second, the Company's patented dual-echo perfusion technology will be developed as part of IB Neuro 1.1. With this proprietary technology DSC (dynamic susceptibility contrast) and DCE (dynamic contrast enhanced) perfusion data can be simultaneously collected while using only a single dose of contrast agent. IB Neuro 1.1. will incorporate the tools to generate relevant perfusion parameters including CBV (cerebral blood volume), CBF (cerebral blood flow) as well as Ktrans, a marker of vascular permeability. A third objective is to incorporate the functionality necessary to more specifically support the evaluation of perfusion data for the evaluation of stroke. Each of these product development objectives will be accomplished in the context of receiving frequent feedback from the Company's luminary sites. This will position the Company for the multi-center trials planned for Phase III. Overall the technological niche of IB, which is to develop advanced imaging analysis tools that plug into existing vendors' systems, will enable advanced imaging options to become more widely available to clinics and therefore patients in a cost-effective manner. The result will be to provide the best and most state-of-the- art patient care on a more widespread basis. This has the potential to shift current clinical practice paradigms with regard to how treatments are planned and monitored, as none of these proven advanced technologies have been previously available on a wide-spread basis. PUBLIC HEALTH RELEVANCE: The goal of this Phase II SBIR proposal is to enable the Company, Imaging Biometrics LLC, to continue its development and distribution of innovative and proven perfusion and diffusion analysis software for the evaluation of brain tumors and stroke. While stand-alone options are available, the primary approach is to develop the software to plug into existing vendors' systems. With this approach the best and most up-to-date image analysis software can be made available on a widespread and cost-effective basis, which has the potential to shift current clinical practice paradigms for treatment planning and monitoring.