Establishment of a UK-wide network to facilitate the acquisition of quality assured FDG-PET data for clinical trials in lymphoma
Establishment of a UK-wide network to facilitate the acquisition of quality assured FDG-PET data for clinical trials in lymphoma
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DOI：
10.1093/annonc/mdq428
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发表时间：
2011-03-01
影响因子：
50.5
通讯作者：
O'Doherty, M. J.
中科院分区：
文献类型：
--
作者：
Barrington, S. F.;MacKewn, J. E.;O'Doherty, M. J.
背景资料：需要多中心试验来确定[氟-18]-2-氟-2-脱氧-D-葡萄糖-正电子发射断层扫描成像如何指导癌症治疗。在质量控制（QC），扫描采集和报告的一致性是强制性的高质量的结果，这是跨sites.Methods：一个国家的正电子发射断层扫描（PET）临床试验网络（CTN）已经成立了一个“核心实验室”，以协调QC和解释扫描。CTN参与了霍奇金淋巴瘤的试验[随机III期试验，以确定FDG-PET成像在临床IA/IIA期霍奇金淋巴瘤（RAPID）中的作用，以及随机III期试验，以评估使用FDG-PET成像在新诊断的霍奇金淋巴瘤患者中的反应适应性治疗，晚期霍奇金淋巴瘤（RATHL）]和弥漫性大B细胞淋巴瘤[弥漫性大B细胞淋巴瘤2个周期化疗后FDG-PET的预后价值的盲法评价]。细胞非霍奇金淋巴瘤，R-CHOP-21与R-CHOP-14试验的子研究（R-CHOP PET子研究）]。批准加入需要扫描仪验证和同意遵循标准的QC协议。扫描被转移到核心实验室，并根据预定的criteria.Results集中报告：在15台扫描仪上进行了鉴定程序。所有扫描仪都能够证明必要的定量准确度，并且在必要时修改图像重建后，扫描仪证明了具有可比性的恢复系数（RC），表明性能相似。13 mm球的平均RC（+/- 1标准差）为0.56 +/- 0.095。444的473例（94%）患者在RAPID和67的73例（92%）患者在RATHL的报告可用于随机化therapy.Conclusions：CTN已使一致的质量保证PET结果，以获得从多个中心的临床决策的时间。这一制度将大大加强审判结果。
Background: Multicentre trials are required to determine how [fluorine-18]-2-fluoro-2-deoxy-D-glucose-positron emission tomography imaging can guide cancer treatment. Consistency in quality control (QC), scan acquisition and reporting is mandatory for high-quality results, which are comparable across sites.Methods: A national positron emission tomography (PET) clinical trials network (CTN) has been set up with a 'core laboratory' to coordinate QC and interpret scans. The CTN is involved in trials in Hodgkin's lymphoma [Randomised Phase III trial to determine the role of FDG-PET Imaging in Clinical Stages IA/IIA Hodgkin's Disease (RAPID) and Randomised Phase III trial to assess response adapted therapy using FDG-PET imaging in patients with newly diagnosed, advanced Hodgkin lymphoma (RATHL)] and diffuse large B-cell lymphoma [Blinded evaluation of prognostic value of FDG-PET after 2 cycles of chemotherapy in diffuse large B-cell Non-Hodgkins Lymphoma, a sub-study of the R-CHOP-21 vs R-CHOP-14 trial (R-CHOP PET substudy)]. Approval to join requires scanner validation and agreement to follow a standard QC protocol. Scans are transferred to the core laboratory and reported centrally according to predetermined criteria.Results: The qualification procedure was carried out on 15 scanners. All scanners were able to demonstrate the necessary quantitative accuracy, and following modification of image reconstruction where necessary, scanners demonstrated comparable recovery coefficients (RCs) indicating similar performance. The average RC (+/- 1 standard deviation) was 0.56 +/- 0.095 for the 13-mm sphere. Reports from 444 of 473 (94%) patients in RAPID and 67 of 73 (92%) patients in RATHL were available for randomisation of therapy.Conclusions: The CTN has enabled consistent quality assured PET results to be obtained from multiple centres in time for clinical decision making. The results of trials will be significantly strengthened by this system.