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

• 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
• 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

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).

说明(申请人提供)：本申请是对NOT-CA-13-011通知的回应，NOT-CA-13-011是对PAR-11-150“用于评价癌症治疗反应的定量成像(U01)”科学范围的具体要求和方面的澄清，本通知声明“...本通知的具体目的是增加一个机会，使应用程序只专注于支持QIN网络范围的研究资源。”在为国家癌症治疗事业服务的14年中，美国放射成像网络学会(ACRIN)进行了许多前瞻性临床试验，以评估成像在确定治疗反应以及在疾病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(AIM 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率和有效的临床研究。拟议的ECOG-ACRIN QIN资源将通过使QIN研究人员能够将新的QIN方法应用于适当的临床试验来实现这一目标。作为QINI的一部分，拟议的ECOG-ACRIN QIN资源将作为评价成像和相关数据质量保证的方法和指标的科学场所，重点是了解产生高质量成像研究的高效率和有效现场资格的成本，以及适当确定适当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(AIM 1)目前在每个参与的QIN地点所采用的做法。经社理事会--ACRIN秦资源将进一步充当资源开发平台(目标2和3)。ECOG-ACRIN与布朗统计中心联合，提议从已完成的ACRIN研究中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量化工具整合到预期的国家临床试验网络研究(AIM 3)中，将QIN工作组平台上的专业知识--PET、MRI、CT、成像统计设计和信息学--带到临床试验中。作为实验成像科学委员会(EISC)、生物标记物小组和成像科学咨询委员会(ISAC)的领导人，ECOG-ACRIN QIN资源PI站在ECOG-ACRIN临床试验开发结构的第一线，这些委员会在提交NCI供审议之前审查成像研究，从而为QIN实验室项目的前瞻性评估(目标3)寻找适当的机会打开大门。