Sites were required to complete contouring and dynamic analysis by ≥ 2 NMPs on benchmarking cases (n = 6) assessing biological tumour volume (BTV) delineation (3 × FET1) and image interpretation (3 × FET3). Data was reviewed by experts and violations noted. BTV definition includes tumour-to-background ratio (TBR) threshold of 1.6 with crescent-shaped background contour in the contralateral normal brain. Recurrence/pseudoprogression interpretation (FET3) required assessment of maximum TBR (TBRmax), dynamic analysis (time activity curve [TAC] type, time to peak), and qualitative assessment. Intraclass correlation coefficient (ICC) assessed volume agreement, coefficient of variation (CoV) compared maximum/mean TBR (TBRmax/TBRmean) across cases, and pairwise analysis assessed spatial (Dice similarity coefficient [DSC]) and boundary agreement (Hausdorff distance [HD], mean absolute surface distance [MASD]).
Data was accrued from 21 NMPs (10 centres, n ≥ 2 each) and 20 underwent review. The initial pass rate was 93/119 (78.2%) and 27/30 requested resubmissions were completed. Violations were found in 25/72 (34.7%; 13/12 minor/major) of FET1 and 22/74 (29.7%; 14/8 minor/major) of FET3 reports. The primary reasons for resubmission were as follows: BTV over-contour (15/30, 50.0%), background placement (8/30, 26.7%), TAC classification (9/30, 30.0%), and image interpretation (7/30, 23.3%). CoV median and range for BTV, TBRmax, and TBRmean were 21.53% (12.00-30.10%), 5.89% (5.01-6.68%), and 5.01% (3.37-6.34%), respectively. BTV agreement was moderate to excellent (ICC = 0.82; 95% CI, 0.63-0.97) with good spatial (DSC = 0.84 ± 0.09) and boundary (HD = 15.78 ± 8.30 mm; MASD = 1.47 ± 1.36 mm) agreement.
The FIG study credentialing program has increased expertise across study sites. TBRmax and TBRmean were robust, with considerable variability in BTV delineation and image interpretation observed.
方法:在基准病例(n=6)评估生物肿瘤体积(BTV)轮廓(3×FET1)和图像解释(3×FET3)上,需要通过≥2NMPs来完成轮廓和动态分析。专家审查了数据,并指出了违规行为。BTV定义包括肿瘤背景比(TBR)阈值为1.6,在对侧正常脑中具有新月形背景轮廓。复发/假性进展解释(FET3)需要评估最大TBR(TBRmax),动态分析(时间活动曲线[TAC]型,到达峰值的时间),和定性评估。组内相关系数(ICC)评估体积协议,变异系数(CoV)比较不同病例的最大/平均TBR(TBRmax/TBRmean),和成对分析评估空间(骰子相似系数[DSC])和边界一致性(豪斯多夫距离[HD],平均绝对表面距离[MASD])。
结果:数据来自21个NMP(10个中心,各n≥2个),20个接受了审查。最初的通过率为93/119(78.2%),并且完成了27/30要求的重新提交。在FET1的25/72(34.7%;13/12次/大)和FET3的22/74(29.7%;14/8次/大)报告中发现了违规行为。重新提交的主要原因如下:BTV过度轮廓(15/30,50.0%),背景放置(8/30,26.7%),TAC分类(9/30,30.0%),和图像解释(7/30,23.3%)。BTV的CoV中位数和范围,TBRmax,TBRmean为21.53%(12.00-30.10%),5.89%(5.01-6.68%),和5.01%(3.37-6.34%),分别。BTV一致性中等至优秀(ICC=0.82;95%CI,0.63-0.97),具有良好的空间(DSC=0.84±0.09)和边界(HD=15.78±8.30mm;MASD=1.47±1.36mm)一致性。
结论:FIG研究认证计划增加了研究地点的专业知识。TBRmax和TBRmean是稳健的,观察到的BTV描绘和图像解释具有相当大的可变性。