Quantitative Imaging for Assessing Breast Cancer Response to Treatment

描述（由申请人提供）：该项目的目标是改进基于mri的定量成像（Ql）的整合，以评估临床试验中接受乳腺癌术前（新辅助）治疗的女性对治疗的反应。我们将以现有的ISPY临床试验项目为基础，其中包括一系列以新辅助治疗为重点的乳腺癌试验。ISPY-1于2002年开始进行与标准护理化疗相关的影像学和组织生物标志物的相关研究，并已发展为个体化治疗和靶向治疗。ISPY-2于2010年3月开业，遵循适应性II期设计，评估乳腺癌的多种靶向治疗。多个治疗组的随机化部分基于ACRIN 6657 （ISPY-1的成像成分）的初步发现对肿瘤体积的MRI测量。拟议的定量成像网络（QIN）项目将集中在三个关键领域，以最大限度地提高Ql评估乳腺癌药物治疗策略的有效性和可靠性。在第一个目标下，我们将发展质素保证程序，以实施更客观的标准，以进行初步的场地资格、持续的影像质素评估，以及接受考试作定量分析。在第二个目标下，我们将在类似于ISPY-2的患者队列中进行可重复性研究，以获得关于乳房MRI定量测量的可变性的重要信息，这些信息可用于改进对反应结果的解释。在第三个目标下，我们将在ISPY和新辅助来曲唑治疗绝经后ER+ DCIS的II期试验中测试几种新的影像学指标，以预测治疗反应。该项目将与美国放射成像网络学院（ACRIN）成像核心和工业合作伙伴Sentinelle Medical， Inc.合作进行。为了最大限度地提高秦项目产品转化为临床实践的效率，ACRIN TRIAD信息系统和Sentinelle Aegis软件系统都将与ISPY-2 TRANSCEND信息系统通信，该信息系统将成像与caBIG支持的ISPY-2试验数据库连接起来。

DESCRIPTION (provided by applicant): The goal of this project is the improved integration of MRI-based quantitative imaging (Ql) for evaluating response to treatment in clinical trials of women receiving pre-operative (neoadjuvant) treatment for breast cancer. We will build on the existing ISPY clinical trials program, which encompasses a series of breast cancer trials focused in the neoadjuvant setting. ISPY-1 started in 2002 with correlative studies of imaging and tissue biomarkers in association with standard of care chemotherapy and has evolved toward individualized treatment with targeted therapies. ISPY-2, which opened in March 2010, follows an adaptive phase II design to evaluate multiple targeted therapies for breast cancer. Randomization to the multiple treatment arms adapts based in part on the MRI measurement of tumor volume as a result of preliminary findings from ACRIN 6657, the imaging component of ISPY-1. The proposed Quantitative Imaging Network (QIN) project will focus in three areas critical to maximizing the effectiveness and reliability of Ql for evaluating drug treatment strategies for breast cancer. Under the first aim, we will develop a quality assurance (QA) process that will be used to implement more objective criteria for initial site qualification, ongoing assessment of image quality and exam acceptance for quantitative analysis. Under the second aim, we will conduct a repeatability study in a patient cohort similar to ISPY-2 to obtain important information about the variability of quantitative measurements made from breast MRI that can be used to improve the interpretation of response results. Under the third aim, we will test several new imaging metrics for predicting treatment response in both ISPY and a phase II trial of neoadjuvant letrozole for treatment of post- menopausal ER+ DCIS. This project will be conducted in partnership with the American College of Radiology Imaging Network (ACRIN) Imaging Core and industrial partner Sentinelle Medical, Inc. In order to maximize the efficiency with which products of this QIN project can be translated into clinical practice, both the ACRIN TRIAD informatics system and the Sentinelle Aegis software system will communicate with the ISPY-2 TRANSCEND informatics system linking imaging with the caBIG supported ISPY-2 trial database.