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

基本信息

批准号：
8537122
负责人：
Nola M. Hylton-Watson
金额：
$ 51.63万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
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/8537122
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

项目摘要

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）：该项目的目标是改进基于 MRI 的定量成像 (Q1) 的集成，用于评估接受乳腺癌术前（新辅助）治疗的女性的临床试验中对治疗的反应。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 于 2002 年开始，对与标准护理化疗相关的影像学和组织生物标志物进行相关研究，并已发展为靶向治疗的个体化治疗。 ISPY-2 于 2010 年 3 月开业，采用适应性 II 期设计，以评估乳腺癌的多种靶向疗法。多个治疗组的随机化部分基于肿瘤体积的 MRI 测量，这是 ISPY-1 的成像组件 ACRIN 6657 的初步发现的结果。拟议的定量成像网络（QIN）项目将重点关注三个关键领域，这些领域对于最大限度地提高 Q1 评估乳腺癌药物治疗策略的有效性和可靠性至关重要。根据第一个目标，我们将开发一个质量保证 (QA) 流程，用于为初始站点资格、图像质量持续评估和定量分析考试验收实施更客观的标准。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，以获得有关乳房 MRI 定量测量变异性的重要信息，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，用于预测治疗反应。该项目将与美国放射成像网络学院 (ACRIN) Imaging Core 和行业合作伙伴 Sentinelle Medical, Inc. 合作进行。为了最大限度地提高该 QIN 项目产品转化为临床实践的效率，双方ACRIN TRIAD 信息学系统和 Sentinelle Aegis 软件系统将与 ISPY-2 TRANSCEND 信息学系统进行通信，将成像与 caBIG 支持的 ISPY-2 试验数据库连接起来。