Quantitative Imaging for Assessing Breast Cancer Response to Treatment

用于评估乳腺癌治疗反应的定量成像

• 批准号: 8108104
• 负责人: Nola M. Hylton-Watson
• 金额: $ 63.57万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-26 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8108104
• 关键词: Address; American College of Radiology Imaging Network; Area; Biological Markers; Breast; Cancer Patient; Clinical Trials; Clinical Trials Database; Collaborations; Computer software; Correlative Study; Data; Databases; Development; Effectiveness; Genomics; Goals; Image; Image Analysis; Imaging Phantoms; Informatics; Letrozole; Link; Magnetic Resonance Imaging; Mammary Neoplasms; Measurement; Measures; Medical; Methods; Metric; Molecular Profiling; Neoadjuvant Therapy; Noninfiltrating Intraductal Carcinoma; Patients; Pharmaceutical Preparations; Phase; Phase II Clinical Trials; Postmenopause; Principal Investigator; Process; Protocols documentation; Randomized; Recruitment Activity; Research Infrastructure; Series; Site; System; Testing; Tissues; Translating; Tumor Volume; Woman; arm; base; cancer Biomedical Informatics Grid; cancer therapy; chemotherapy; clinical practice; clinically relevant; cohort; design; improved; malignant breast neoplasm; patient population; programs; prospective; quality assurance; response; software systems; standard of care; treatment response; treatment strategy

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.

描述（由申请人提供）：本项目的目标是改进基于MRI的定量成像（Ql）的整合，用于评价接受乳腺癌术前（新辅助）治疗的女性临床试验中的治疗反应。我们将建立在现有的ISPY临床试验计划的基础上，该计划包括一系列专注于新辅助治疗的乳腺癌试验。ISPY-1始于2002年，与标准治疗化疗相关的成像和组织生物标志物的相关研究，并已发展为靶向治疗的个体化治疗。ISPY-2于2010年3月开放，遵循适应性II期设计，以评估乳腺癌的多种靶向治疗。根据ACRIN 6657（ISPY-1的成像组分）的初步结果，部分基于肿瘤体积的MRI测量结果调整多个治疗组的随机化。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，我们将开发一个质量保证（QA）流程，用于实施更客观的标准，用于初始网站资格，图像质量的持续评估和定量分析的考试验收。在第二个目标下，我们将在类似于ISPY-2的患者队列中进行重复性研究，以获得有关乳腺MRI定量测量变异性的重要信息，这些信息可用于改善缓解结果的解释。在第三个目标下，我们将在ISPY和来曲唑新辅助治疗绝经后ER+ DCIS的II期试验中测试几种新的成像指标，以预测治疗反应。该项目将与美国放射学会成像网络（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QIN项目产品转化为临床实践的效率，ACRIN TRIAD信息系统和Sentinelle Aegis软件系统将与ISPY-2 TRANSCEND信息系统通信，将成像与caBIG支持的ISPY-2试验数据库连接起来。