Quantitative Magnetic Resonance Imaging Phantoms

项目总结 此SBIR第二阶段提案的总体目标是提炼和评估高级定量磁性 磁共振成像(MRI)模体，模拟脂肪、铁和纤维化的同时存在。脂肪，铁 纤维化是许多重要疾病状态的三个主要组织学共存特征。幻影是 高度受控的测试对象，准确反映正常和病理情况下的组织特征 纸巾。在过去的5年中引入的新兴的定量MRI方法越来越多地被用于非 在临床护理和临床试验中进行侵入性诊断、分期和治疗监测。然而，缺乏 模拟在疾病状态下经历的脂肪、铁和纤维化的组合的可存活的MRI幻象是一种 开发新的定量磁共振生物标记物的主要障碍以及有效的质量保证 临床环境。核磁共振扫描仪的质量保证和资格鉴定也需要这样的幻影 用于多中心药物开发试验。 Calimetrix，LLC和威斯康星大学麦迪逊分校之间的这项合作第二阶段提案将 建立在STTR第一阶段项目中开发的成功的概念验证原型的基础上。具体地说，这 提案将完善和评估新的定量MRI模体，以验证和质量保证 核磁共振技术用于评估组织中的脂肪、铁和纤维化。调查小组将优化和确定 模体的制造精度(目标1)以及其制造精度(目标2)将进行 加速保质期测试(AIM 3)，并将在不同地点的多中心研究中评估该模型， MRI供应商和两个领域的优势(目标4)。成功设计、开发和验证高级 准确反映组织特征的模体是发展和传播的关键一步 定量成像生物标记物，这将通过降低成本、提高安全性和 改善疾病的早期诊断和治疗，影响数百万美国人的健康。

PROJECT SUMMARY The overall goal of this SBIR Phase II proposal is to refine and evaluate advanced quantitative magnetic resonance imaging (MRI) phantoms that mimic the simultaneous presence of fat, iron and fibrosis. Fat, iron and fibrosis are three principal histological coexisting features of many important disease states. Phantoms are highly controlled test objects that accurately reflect tissue characteristics in both normal and pathological tissues. Emerging quantitative MRI methods introduced in the past ~5 years are increasingly used for non- invasive diagnosis, staging and treatment monitoring in both clinical care and clinical trials. However, the lack of viable MRI phantoms that mimic the combination of fat, iron and fibrosis experienced in disease states is a major barrier to the development of new quantitative MRI biomarkers, as well as effective quality assurance in clinical environments. Such phantoms are also needed for quality assurance and qualification of MRI scanners for use in multicenter drug development trials. This collaborative Phase II proposal between Calimetrix, LLC, and the University of Wisconsin-Madison will build upon the successful proof-of-concept prototype developed in an STTR Phase I project. Specifically, this proposal will refine and evaluate novel quantitative MRI phantoms for the validation and quality assurance of MRI techniques to assess fat, iron and fibrosis in tissue. The investigative team will optimize and determine the manufacturing accuracy of the phantom (Aim 1), as well as its manufacturing precision (Aim 2), will conduct accelerated shelf-life testing (Aim 3), and will evaluate the phantom in a multi-center study across various sites, MRI vendors, and two field strengths (Aim 4). Successful design, development and validation of advanced phantoms that accurately reflect tissue characteristics are a critical step in the development and dissemination of quantitative imaging biomarkers, which will have major impact by reducing cost, improving safety, and improving early diagnosis and treatment of disease, affecting the health of millions of Americans.