Repeatability of 18F-FDG PET in a Multicenter Phase I Study of Patients with Advanced Gastrointestinal Malignancies
Repeatability of 18F-FDG PET in a Multicenter Phase I Study of Patients with Advanced Gastrointestinal Malignancies
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DOI：
10.2967/jnumed.109.063347
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发表时间：
2009-10-01
影响因子：
9.3
通讯作者：
Galbraith, Susan M.
中科院分区：
文献类型：
--
作者：
Velasquez, Linda M.;Boellaard, Ronald;Galbraith, Susan M.
F-18-FDG PET常用于多中心肿瘤临床试验中监测肿瘤缓解。本研究评估了多中心I期肿瘤学试验中重复基线F-18-FDG PET研究测量的几个半定量标准化摄取值（平均SUV [SUV mean]、最大SUV [SUV max]、峰值SUV [SUV peak]和最大像素值70%处的三维等值线[SUV 70%]）的可重复性。方法：对62例连续入组的患者进行双基线F-18-FDG PET研究。通过SUV平均值、SUV最大值、SUV峰值和SUV 70%评估肿瘤代谢活性。评估了符合推荐的图像采集指南和质量保证（QA）标准对SUV重复性的影响。在多观察者和单观察者环境中，对所有患者和通过QA的亚组进行相对于基线值平均值的绝对差异的汇总统计和重复性分析。通过重复性系数、受试者内变异系数（CV）和所有SUV参数平均基线差异的置信区间评估基线测量的受试者内精密度。结果如下：2个SUV基线测量值之间的平均差异较小，范围为-2.1%至1.9%，这些平均差异的95%置信区间在评估的SUV参数中的最大半宽约为5.6%。对于SUVmax，QA多观察者和单观察者数据集的受试者内CV为10.7%-12.8%，完整数据集的受试者内CV为16%。QA数据集的95%重复性系数范围为-28.4%至39.6%，完整数据集的95%重复性系数范围为-34.3%至52.3%。结论：在多观察者和单观察者设置下，对于完整数据集和QA数据集，双基线F-18-FDG PET扫描的重复性结果对于评估的所有SUV参数均相似。集中质量保证和数据分析将平均SUVmax的受试者内CV从15.9%提高到10.7%。在多中心多观察者非QA环境中，代谢反应的预测值为-34%和52%，在集中QA环境中，范围为-26%至39%。这些结果支持在多中心肿瘤临床试验中使用F-18-FDG PET进行肿瘤评估。
F-18-FDG PET is often used to monitor tumor response in multicenter oncology clinical trials. This study assessed the repeatability of several semiquantitative standardized uptake values (mean SUV [SUVmean], maximum SUV [SUVmax], peak SUV [SUVpeak], and the 3-dimensional isocontour at 70% of the maximum pixel value [SUV70%]) as measured by repeated baseline F-18-FDG PET studies in a multicenter phase I oncology trial. Methods: Double-baseline F-18-FDG PET studies were acquired for 62 sequentially enrolled patients. Tumor metabolic activity was assessed by SUVmean, SUVmax, SUVpeak, and SUV70%. The effect on SUV repeatability of compliance with recommended image-acquisition guidelines and quality assurance (QA) standards was assessed. Summary statistics for absolute differences relative to the average of baseline values and repeatability analysis were performed for all patients and for a subgroup that passed QA, in both a multi- and a single-observer setting. Intrasubject precision of baseline measurements was assessed by repeatability coefficients, intrasubject coefficients of variation (CV), and confidence intervals on mean baseline differences for all SUV parameters. Results: The mean differences between the 2 SUV baseline measurements were small, varying from -2.1% to 1.9%, and the 95% confidence intervals for these mean differences had a maximum half-width of about 5.6% across the SUV parameters assessed. For SUVmax, the intrasubject CV varied from 10.7% to 12.8% for the QA multi- and single-observer datasets and was 16% for the full dataset. The 95% repeatability coefficients ranged from -28.4% to 39.6% for the QA datasets and up to -34.3% to 52.3% for the full dataset. Conclusion: Repeatability results of double-baseline F-18-FDG PET scans were similar for all SUV parameters assessed, for both the full and the QA datasets, in both the multi- and the single-observer settings. Centralized quality assurance and analysis of data improved intrasubject CV from 15.9% to 10.7% for averaged SUVmax. Thresholds for metabolic response in the multicenter multiobserver non-QA settings were -34% and 52% and in the range of -26% to 39% with centralized QA. These results support the use of F-18-FDG PET for tumor assessment in multicenter oncology clinical trials.