Fanti Stefano, Minozzi Silvia, Morigi Joshua James, Giesel Frederik, Ceci Francesco, Uprimny Christian, Hofman Michael S, Eiber Matthias, Schwarzenbock Sarah, Castellucci Paolo, Bellisario Cristina, Chauvie Stéphane, Bergesio Fabrizio, Emmett Louise, Haberkorn Uwe, Virgolini Irene, Schwaiger Markus, Hicks Rodney J, Krause Bernd J, Chiti Arturo
Nuclear Medicine Unit, University of Bologna, S. Orsola Hospital Bologna, Bologna, Italy.
Department of Epidemiology, Lazio Regional Health Service, Rome, Italy.
Eur J Nucl Med Mol Imaging. 2017 Sep;44(10):1622-1635. doi: 10.1007/s00259-017-3725-1. Epub 2017 May 23.
After primary treatment, biochemical relapse (BCR) occurs in a substantial number of patients with prostate cancer (PCa). PET/CT imaging with prostate-specific membrane antigen based tracers (68Ga-PSMA) has shown promising results for BCR patients. However, a standardized image interpretation methodology has yet to be properly agreed. The aim of this study, which was promoted and funded by European Association of Nuclear Medicine (EANM), is to define standardized image interpretation criteria for 68Ga-PSMA PET/CT to detect recurrent PCa lesions in patients treated with primary curative intent therapy (radical prostatectomy or radiotherapy) who presented a biochemical recurrence. In the first phase inter-rater agreement between seven readers from seven international centers was calculated on the reading of 68Ga-PSMA PET/CT images of 49 patients with BCR. Each reader evaluated findings in five different sites of recurrence (local, loco-regional lymph nodes, distant lymph nodes, bone, and other). In the second phase the re-analysis was limited to cases with poor, slight, fair, or moderate agreement [Krippendorff's (K) alpha<0.61]. Finally, on the basis of the consensus readings, we sought to define a list of revised consensus criteria for 68Ga-PSMA PET/CT interpretation.
Between-reader agreement for the presence of anomalous findings in any of the five sites was only moderate (K's alpha: 0.47). The agreement improved and became substantial when readers had to judge whether the anomalous findings were suggestive for a pathologic, uncertain, or non-pathologic image (K's alpha: 0.64). K's alpha calculations for each of the five sites of recurrence were also performed and evaluated. First Delphi round was thus conducted. A more detailed definition of the criteria was proposed by the project coordinator, which was then discussed and finally agreed by the seven readers. After the second Delphi round only four cases of disagreement still remained. These were evaluated for a final round, allowing a final agreement table to be written.
We hope that by developing these consensus guidelines on the interpretation of 68Ga-PSMA PET/CT, clinicians reporting these studies will be able to provide more consistent clinical reports and that within clinical trials, abnormality classifications will be harmonized, allowing more robust assessment of its diagnostic performance.
在初始治疗后，大量前列腺癌（PCa）患者会出现生化复发（BCR）。基于前列腺特异性膜抗原的示踪剂（68Ga - PSMA）的PET/CT成像在BCR患者中显示出了有前景的结果。然而，尚未就标准化的图像解读方法达成恰当共识。这项由欧洲核医学协会（EANM）推动并资助的研究旨在为68Ga - PSMA PET/CT定义标准化的图像解读标准，以检测接受了根治性治疗（根治性前列腺切除术或放疗）且出现生化复发的患者中的复发性PCa病灶。在第一阶段，计算了来自七个国际中心的七位阅片者对49例BCR患者的68Ga - PSMA PET/CT图像的阅片者间一致性。每位阅片者评估了五个不同复发部位（局部、局部区域淋巴结、远处淋巴结、骨骼和其他）的检查结果。在第二阶段，重新分析仅限于一致性较差、一般、尚可或中等的病例[克里彭多夫（K）α<0.61]。最后，基于共识阅片结果，我们试图确定一份修订后的68Ga - PSMA PET/CT解读共识标准清单。
五位阅片者对五个部位中任何一个部位异常表现的一致性仅为中等（Kα：0.47）。当阅片者必须判断异常表现提示病理性、不确定或非病理性图像时，一致性有所提高且达到了实质性水平（Kα：0.64）。还对五个复发部位各自进行了Kα计算和评估。因此进行了第一轮德尔菲法。项目协调员提出了更详细的标准定义，随后由七位阅片者进行讨论并最终达成一致。第二轮德尔菲法后，仅剩下四例存在分歧的病例。对这些病例进行了最后一轮评估，从而形成了最终的一致意见表。
我们希望通过制定这些关于68Ga - PSMA PET/CT解读的共识指南，报告这些研究的临床医生能够提供更一致的临床报告，并且在临床试验中，异常分类将得到统一，从而能够更有力地评估其诊断性能。
