Harmonized PET Reconstructions for Cancer Clinical Trials

描述（由申请人提供）：正电子发射断层扫描（PET）是一种固有的定量医学成像技术。当与提供恶性肿瘤状态有价值信息的放射性药物联合使用时，PET是一种潜在的强大成像方式，可用于评估多中心临床试验中对新癌症疗法的反应。商用PET扫描仪系统的制造商，然而，可以理解的是，努力产生更高质量的诊断（即检测任务优化）图像，以实现市场差异化，但不一定是最准确的定量数据。图像重建算法的最新进展提高了图像质量，但矛盾的是增加了PET扫描仪之间的定量差异。由此产生的定量准确性的差异使多中心临床试验中数据的比较变得混乱。国家和国际上已经开始努力使影响PET定量的协议标准化。然而，在协调图像重建方法和参数以解决多中心试验中PET图像精度的巨大变异性问题方面的努力有限。这种依赖于尺寸和扫描仪的可变性降低了临床试验的质量，因为需要更多的患者累积和/或导致在急需的癌症治疗试验中出现不确定的结果。拟议的项目将通过结合严格的NIST可追溯校准标准和开发行业支持的协调PET图像重建范例来解决这一问题，提供具有已知误差特征的定量准确和可重复的测量。该项目得到了所有三家主要PET/CT扫描仪制造商的支持，并通过核医学协会的临床试验网络提供了便利，将主要由三家领先的PET/CT学术机构进行，这些机构在定量成像方面拥有丰富的经验，并与三家制造商建立了实质性的合作记录。还将根据需要从其他PET中心收集数据，为17种不同的当前老式PET/CT扫描仪提供具有代表性的数据和统一的重建解决方案。

DESCRIPTION (provided by applicant): Positron emission tomography (PET) is an inherently quantitative medical imaging technique. When combined with radiopharmaceuticals that provide valuable information on the state of malignancies, PET is a potentially powerful imaging modality for assessing response to new cancer therapies in multi-center clinical trials. Manufacturers of commercial PET scanner systems, however, understandably strive to generate higher quality diagnostic (i.e. detection task optimized) images to achieve market differentiation, but not necessarily the most accurate quantitative data. Recent advances in image reconstruction algorithms enhance image quality, but have paradoxically increased quantitative differences between PET scanners. The resulting variations in quantitative accuracy confound the comparisons of data within multi-center clinical trials. National and international efforts have been initiated to standardize protocols that impact PET quantitation. However, there has been limited effort to harmonize image reconstruction methodologies and parameters to resolve the problem of the substantial variability in PET image accuracy in multi-center trials. This size- and scanner-dependent variability degrades the quality of clinical trials by requiring more patient accrual and/or leading to inconclusive results in tests of badly needed cancer therapies. The proposed project will solve this problem through a combination of rigorous NIST traceable calibration standards combined with the development of an industry-supported harmonized PET image reconstruction paradigm providing quantitatively accurate and reproducible measurements with known errors characteristics. The project is supported by all three major PET/CT scanner manufacturers, facilitated through the Society of Nuclear Medicine's Clinical Trials Network, and will be primarily performed by three leading PET/CT academic institutions with extensive experience in quantitative imaging and established track records of substantial collaboration with the three manufacturers. Data will also be collected from other PET centers as needed to provide representative data and harmonized reconstruction solutions for the full range of 17 different current vintage PET/CT scanners.