ECOG-ACRIN-Based QIN Resource for Advancing Quantitative Cancer Imaging in Clinical Trials

基于 ECOG-ACRIN 的 QIN 资源，用于推进临床试验中的定量癌症成像

基本信息

批准号：
8802078
负责人：
MITCHELL D. SCHNALL
金额：
$ 66.27万
依托单位：
ECOG-ACRIN MEDICAL RESEARCH FOUNDATION
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-03-20 至 2020-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8802078
关键词：
Advisory Committees American College of Radiology American College of Radiology Imaging Network Biological Markers Clinical Research Clinical Trials Data Data Reporting Data Set Development Diagnostic Disease Eastern Cooperative Oncology Group Effectiveness Environment Evaluation Evolution Goals Image Image Analysis Influentials Informatics Institute of Medicine (U.S.)Knowledge Laboratories Lead Link Magnetic Resonance Imaging Malignant Neoplasms Mediating Metadata Methodology Methods Modality Multicenter Trials Mutation National Clinical Trials Network Network-based Outcome Participant Patients Pharmaceutical Preparations Positron-Emission Tomography Process Prospective Studies Protocols documentation Quality Control Reporting Research Research Personnel Resistance Resource Development Resources Role Science Services Site Source Specific qualifier value Structure System Testing Therapeutic Translating Treatment Efficacy Validation Work X-Ray Computed Tomography cancer cell cancer imaging cancer therapy cost design image archival system imaging modality improved member molecular oncology novel oncology prognostic prospective public health relevance quality assurance quantitative imaging response safety testing statistical center tool working group

项目摘要

DESCRIPTION (provided by applicant): This application is in response to Notice NOT-CA-13-011, which is a clarification of the specific requirements and aspects of the scientific scope of PAR-11-150 "Quantitative Imaging for Evaluation of Responses to Cancer Therapies (U01)," This Notice states "... the specific purpose of this Notice is to add an opportunity for applicatios to be focused only on supporting QIN network-wide research resources." In 14 years of service to the national undertaking of curing cancer, the American College of Radiology Imaging Network (ACRIN) has conducted many prospective clinical trials to evaluate imaging's role in defining therapeutic response and in the prognostic and diagnostic evaluation of disease. As a QIN U01Center, the ECOG-ACRIN QIN Resource will also leverage ECOG-ACRIN's clinical trial development structure (Aim 3) to enable prospective testing for methods developed by the QIN. The overall objective of the proposal is efficient and effective clinical research at reasonable cost. The proposed ECOG-ACRIN QIN Resource will achieve that goal by enabling QIN investigators to apply novel QIN methods to appropriate clinical trials. As part of the QIN, the proposed ECOG-ACRIN QIN Resource will act as a scientific site for evaluating methodologies and metrics for quality assurance of imaging and associated data, focusing on understanding the costs of efficient and effective site qualifications that result in high-quality imaging studie and the metrics required to appropriately define the number of participants required for adequate analysis. This project will evaluate quality control at QIN laboratories, comparing practices currently applied by the NCI (e.g., CQIE) and ACR Imaging Core Laboratory (Aim 1) at each participating QIN site. The ECOG-ACRIN QIN Resource will further act as a resource development platform (Aims 2 and 3). ECOG-ACRIN, in league with the Brown Statistical Center, proposes to develop datasets for method testing and validation from completed ACRIN research for assessment of QIN metrics and validation purposes (Aim 2). In the Resource, outcomes and progression data will be made available for correlation with computational findings. Finally, the ECOG-ACRIN QIN Resource will bring expertise across QIN Working Group platforms-in PET, MRI, CT, imaging statistical design, and informatics-to clinical trials by integrating quality assurance and QIN quantitative tools into prospective National Clinical Trial Network research (Aim 3). The ECOG-ACRIN QIN Resource PIs stand at the frontlines within the ECOG-ACRIN clinical trials development structure as leaders of the Experimental Imaging Science Committee (EISC) and Biomarker Group and Imaging Science Advisory Committees (ISAC), which review imaging studies prior to submission to NCI for consideration, and thus open the door to identifying appropriate opportunities for prospective evaluation of QIN laboratory projects (Aim 3).

描述（由申请人提供）：本申请是对通知 NOT-CA-13-011 的回应，该通知澄清了 PAR-11-150“用于评估响应的定量成像”的科学范围的具体要求和方面。癌症治疗 (U01)”，本通知指出“……本通知的具体目的是为应用程序提供一个仅专注于支持 QIN 网络范围研究资源的机会。” 在为国家癌症治疗事业服务 14 年来，美国放射影像学院网络 (ACRIN) 进行了许多前瞻性临床试验，以评估影像学在确定治疗反应以及疾病的预后和诊断评估中的作用。作为 QIN U01 中心，ECOG-ACRIN QIN 资源还将利用 ECOG-ACRIN 的临床试验开发结构（目标 3）对 QIN 开发的方法进行前瞻性测试。该提案的总体目标是以合理的成本进行高效、有效的临床研究。拟议的 ECOG-ACRIN QIN 资源将使 QIN 研究人员能够将新颖的 QIN 方法应用于适当的临床试验，从而实现这一目标。作为 QIN 的一部分，拟议的 ECOG-ACRIN QIN 资源将作为一个科学站点，用于评估成像和相关数据质量保证的方法和指标，重点是了解高效和有效的站点资格的成本，从而获得高质量的结果。成像研究和适当定义充分分析所需的参与者数量所需的指标。该项目将评估 QIN 实验室的质量控制，比较 NCI（例如 CQIE）和 ACR 成像核心实验室（目标 1）在每个参与 QIN 站点当前应用的实践。 ECOG-ACRIN QIN 资源将进一步充当资源开发平台（目标 2 和 3）。 ECOG-ACRIN 与布朗统计中心合作，建议根据已完成的 ACRIN 研究开发用于方法测试和验证的数据集，以评估 QIN 指标和验证目的（目标 2）。在资源中，将提供结果和进展数据，以便与计算结果相关联。最后，ECOG-ACRIN QIN 资源将通过将质量保证和 QIN 定量工具整合到前瞻性国家临床试验网络研究中，将 QIN 工作组平台（PET、MRI、CT、影像统计设计和信息学）的专业知识引入临床试验。目标3）。 ECOG-ACRIN QIN 资源 PI 站在 ECOG-ACRIN 临床试验开发结构的最前线，作为实验成像科学委员会 (EISC) 和生物标志物组以及成像科学咨询委员会 (ISAC) 的领导者，这些委员会在提交之前审查成像研究供 NCI 考虑，从而为确定 QIN 实验室项目前瞻性评估的适当机会打开大门（目标 3）。