Advanced PET/CT Imaging for Improving Clincail Trials

用于改善临床试验的先进 PET/CT 成像

• 批准号: 8249160
• 负责人: Paul E. Kinahan
• 金额: $ 56.22万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-04-15 至 2015-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8249160
• 关键词: Accounting; Biological Markers; Biological Response Modifier Therapy; Biometry; Calibration; Cancer Center; Clinic; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Clinical Trials Design; Data; Development; Dose; Effectiveness; Ensure; Equipment; Error Sources; Evaluation; FPS-FES Oncogene; Future; Glean; Goals; Guidelines; Half-Life; Image; Image Analysis; Imaging Techniques; Industry; Isotopes; Kinetics; Link; Malignant Neoplasms; Malignant neoplasm of prostate; Manufacturer Name; Measurement; Measures; Methods; Metric; Modeling; Multi-Institutional Clinical Trial; Outcome; Outpatients; PET/CT scan; Participant; Patients; Pharmaceutical Preparations; Phase; Phase I Clinical Trials; Phase I/II Trial; Phase III Clinical Trials; Positron-Emission Tomography; Principal Investigator; Protocols documentation; Radiology Specialty; Recommendation; Research Design; Research Personnel; Sample Size; Scanning; Science; Site; Staging; Surrogate Endpoint; Testing; Therapeutic; Therapeutic Agents; Therapy Clinical Trials; Tilia; Tracer; Universities; Variant; Washington; base; cancer care; cancer therapy; cost; design; experience; imaging modality; improved; insight; instrumentation; malignant breast neoplasm; novel; oncology; reconstruction; response; standardize guidelines; tool; tumor; uptake

DESCRIPTION (provided by applicant): The goal of this proposal is to improve cancer clinical trials by enhancing the effectiveness of quantitative PET/CT imaging of tumor response. This has three distinct and linked components; (1) measuring and reducing the bias and variance of multi-center quantitative PET/CT imaging measurements, (2) devising optimal PET image analysis methods appropriate for quantitative PET/CT imaging in clinical trials, and (3) developing and testing guidelines for incorporating quantitative PET/CT imaging as a biomarker and measure of response in cancer clinical trial design. Underlying themes include optimizing the clinical and biologic data that can be gleaned from imaging in the setting of cancer therapy clinical trials, matching the design of the imaging components to the phase and complexity of the cancer clinical therapy trial, and matching the imaging approach to the type of tumor and the therapeutic agent. The mechanism used in the proposal is the development and testing of methods in tandem with existing clinical cancer trials that include PET imaging. This includes imaging studies performed locally at the University of Washington, in small multi-center trials as part of a regional network directed by our cancer center, and as a participant in national multi-center trials. The focus is on early drug trials (Phase I and II studies) and imaging biomarker studies; however, the methods investigated and tools developed will be equally applicable to larger (Phase III) trials and imaging as a surrogate endpoint. The combined results from all three aims will enable clinical investigators, cooperative cancer trial groups, and pharma, to optimize the use of PET imaging in cancer clinical trials and to include considerations for quantitative PET imaging markers in choosing a study design and sample size.

描述（由申请人提供）：该提案的目的是通过提高肿瘤反应的定量PET/CT成像的有效性来改善癌症临床试验。这具有三个不同的链接组件； （1）测量和降低多中心定量PET/CT成像测量的偏差和方差，（2）在临床试验中设计适合定量PET/CT成像的最佳PET图像分析方法，以及（3）制定和测试和测试指南，用于将定量PET/CT成像作为生物标准量和测量的响应型临床临床设计。潜在的主题包括优化临床和生物学数据，这些数据可以从癌症治疗临床试验的设置中从成像中收集，将成像成分的设计与癌症临床治疗试验的相位和复杂性相匹配，并将成像方法与肿瘤类型和治疗剂相匹配。该提案中使用的机制是与包括PET成像的现有临床癌症试验一起开发和测试。这包括在华盛顿大学本地进行的成像研究，在小型多中心试验中，作为我们癌症中心指导的区域网络的一部分，也是国家多中心试验的参与者。重点是早期药物试验（I阶段和II研究）和成像生物标志物研究；但是，所研究的方法和开发的工具将同样适用于较大的（第三阶段）试验和成像作为替代端点。所有三个目标的综合结果将使临床研究人员，合作癌症试验组和制药公司能够优化在癌症临床试验中使用PET成像，并在选择研究设计和样本量时考虑定量PET成像标记。