Advanced PET/CT Imaging for Improving Clinical Trials

 描述（由申请人提供）：我们的总体目标是通过增强肿瘤反应的定量PET/CT成像的有效性来提高新癌症治疗的临床试验效率。在本次更新申请中，我们寻求在多中心临床试验中部署和验证我们在当前项目期间在定量成像网络（QIN）中开发的定量PET成像工具和方法。虽然定量PET成像是评估对潜在癌症治疗的反应的独特强大工具，但它也会受到几种偏倚和变异性来源的影响，从而降低研究效力。此外，需要多中心研究来增加患者的累积率，即使是在早期研究中。这些多中心研究可能会混淆定量准确性，进一步降低研究能力，导致错过评估新疗法的机会。为了加速使用定量PET成像评估癌症疗法，我们有三个不同且相互关联的目标：（1）开发和实施统一的数据库和成像平台，使我们的体模和软件工具能够可行地部署。(2)将我们的定量FDG PET成像工具扩展到多中心研究中的FLT（增殖）和FES（受体状态）。(3)Proximity测试上述工具和方法在临床试验中的整合，使用18F-FES PET成像来评估新的乳腺癌治疗方法。这些方法可以很容易地扩展到其他癌症使用定量PET成像。在多中心临床试验中对定量PET成像工具进行前瞻性测试是迈向采用的重要一步。反过来，这将有助于通过定量成像加速对改进的癌症疗法的有效评估，这将使研究人员、临床医生和癌症患者受益。

 DESCRIPTION (provided by applicant): Our overall goal is to improve the efficiency of clinical trials of new cancer therapies by enhancing the effectiveness of quantitative PET/CT imaging of tumor response. In this renewal application, we seek to deploy and validate in multi-center clinical trials the quantitative PET imaging tools and methods that we have developed within the Quantitative Imaging Network (QIN) during the current project period. While quantitative PET imaging is a uniquely powerful tool to assess response to potential cancer therapies, it is also subject to several sources of bias and variability that degrade study power. In addition, multi-center studies are needed to increase patient accrual rates, even in early-phase studies. These multi-center studies can confound quantitative accuracy, further reducing study power, leading to missed opportunities in evaluating new therapies To accelerate the evaluation of cancer therapies using quantitative PET imaging we have three distinct and linked aims: (1) Develop and implement a unified database and imaging platform that enables feasible deployment of our phantoms and software tools. (2) Extend our quantitative FDG PET imaging tools to FLT (proliferation) and FES (receptor status) in multicenter studies. (3) Prospectively test the integration of the above tools and methods in a clinical trial that uses 18F-FES PET imaging to evaluate new breast cancer therapies. These approaches can be readily extended to other cancers using quantitative PET imaging. The prospective testing of quantitative PET imaging tools in multisite clinical trials is an essential step towards adoption. In turn this will help accelerate the effective evaluation of improved cancer therapies by quantitative imaging, which will benefit investigators, clinicians, and cancer patients.