A Quality Control Program for Quantitative MRI Data Acquisition and Analysis in Multi-site Clinical Trials

项目摘要/摘要 临床治疗已转向更多地使用新辅助化疗(NACT)。 癌症。常用于乳腺癌，为可能的或明显的转移性疾病提供系统治疗， NACT还缩小了原发肿瘤的大小，有利于乳房的保存。定量磁化 磁共振成像(QMRI)是监测肿瘤消退的有效诊断方法。有很多 正在开发的体内癌症监测方法，包括造影剂洗脱法、体积法、 最近，表观扩散系数和质子弛豫时间与肿瘤分期相关。是这样的 影像生物标记物可以在手术前预测病理完全反应(PCR)的结果。这 使医生能够提供基于证据的治疗改进，以减少有害的副作用和 改善患者的预后。 为了从MR图像中获得定量数据，由于硬件和 必须量化MRI制造商和日常操作之间的软件差异。在核磁共振中， 数据取决于用于获取图像的协议，如果只有一个参数出现在 协议会改变。拟议工作的目标是生产、开发和传播一个 多点I-SPY2核磁共振扫描仪比对的TRUE物理标准和质量控制程序 (ACRIN 6698)监测术前化疗缩小肿瘤大小的试验。 身体标准是一个拟人化的乳房体模，能够适合所有商业乳房线圈。 它包含新的人体组织模拟和几何标准，其价值可追溯到国家研究所 标准与技术部(NIST)。能够快速检查协议合规性的分析软件 确定感兴趣的区域，并与NIST测量的基本真实值进行比较 为补充体格标准而开发的。这将使站点资格鉴定和量化 仅由扫描仪性能导致的错误。鉴于MRI协议的参数空间范围很广 包括，拟议的工作的一部分将包括开发特定于图像采集的协议 用于测量比较的肿瘤体积内的表观扩散系数 到周围的健康组织。

Project Summary/Abstract There has been a shift to greater use of neadjuvant chemotherapy (NACT) in the clinical management of cancer. Often used in breast cancer to provide systemic treatment for possible or apparent metastatic disease, NACT also reduces the primary tumor size and facilitates breast conservation. Quantitative magnetic resonance imaging (qMRI) is an effective diagnostic for monitoring tumor regression. There are many methodologies being developed for monitoring cancer in vivo, including contrast agent washout, volumetry, and more recently correlating apparent diffusion coefficients and proton relaxation times to tumor staging. Such imaging biomarkers are predictive of the pathological complete response (pCR) outcome prior to surgery. This enables physicians to provide “evidence based” treatment modifications to reduce deleterious side effects and improve patient outcomes. To obtain quantitative data from MR images, the variations that occur in imaging as a result of hardware and software differences between MRI manufacturers and day-to-day operations must be quantified. In MRI, the data depends on the protocols used to acquire the image, resulting in inconsistencies if even one parameter in the protocol changes. The goal of the proposed work is to produce and develop and disseminate a ground truth physical standard and quality control program for comparison of MRI scanners in the multisite I-SPY2 (ACRIN 6698) trials monitoring pre-operative chemotherapy treatments in the reduction of tumor size. The physical standard is an anthropomorphic breast phantom capable of fitting into all commercial breast coils. It contains novel human tissue mimics and geometric standards with values traceable to the National Institute of Standards and Technology (NIST). Analysis software capable of protocol compliance checks, rapid identification of the regions of interest, and comparison to ground truth values as measured by NIST will be developed to complement the physical standard. This will enable qualification of sites and quantification of error resulting from scanner performance alone. Given the wide breadth of parameter space that MRI protocols encompass, part of the proposed effort will include the development of protocols specific to image acquisition of tumor volumes and for measuring the apparent diffusion coefficient within the tumor volumes as compared to surrounding healthy tissue.