Kaufman Audrey E, Pruzan Alison N, Hsu Ching, Ramachandran Sarayu, Jacobi Adam, Patel Indravadan, Schwocho Lee, Mercuri Michele F, Fayad Zahi A, Mani Venkatesh
Department of Radiology, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
Daiichi Sankyo Inc., Basking Ridge, NJ 07920, United States.
World J Radiol. 2018 Oct 28;10(10):124-134. doi: 10.4329/wjr.v10.i10.124.
To evaluate reproducibility of pulmonary embolism (PE) clot volume quantification using computed tomography pulmonary angiogram (CTPA) in a multicenter setting.
This study was performed using anonymized data in conformance with HIPAA and IRB Regulations (March 2015-November 2016). Anonymized CTPA data was acquired from 23 scanners from 18 imaging centers using each site's standard PE protocol. Two independent analysts measured PE volumes using a semi-automated region-growing algorithm on an FDA-approved image analysis platform. Total thrombus volume (TTV) was calculated per patient as the primary endpoint. Secondary endpoints were individual thrombus volume (ITV), Qanadli score and modified Qanadli score per patient. Inter- and intra-observer reproducibility were assessed using intra-class correlation coefficient (ICC) and Bland-Altman analysis.
Analyst 1 found 72 emboli in the 23 patients with a mean number of emboli of 3.13 per patient with a range of 0-11 emboli per patient. The clot volumes ranged from 0.0041 - 47.34 cm (mean +/- SD, 5.93 +/- 10.15cm). On the second read, analyst 1 found the same number and distribution of emboli with a range of volumes for read 2 from 0.0041 - 45.52 cm (mean +/- SD, 5.42 +/- 9.53cm). Analyst 2 found 73 emboli in the 23 patients with a mean number of emboli of 3.17 per patient with a range of 0-11 emboli per patient. The clot volumes ranged from 0.00459-46.29 cm (mean +/- SD, 5.91 +/- 10.06 cm). Inter- and intra-observer variability measurements indicated excellent reproducibility of the semi-automated method for quantifying PE volume burden. ICC for all endpoints was greater than 0.95 for inter- and intra-observer analysis. Bland-Altman analysis indicated no significant biases.
Semi-automated region growing algorithm for quantifying PE is reproducible using data from multiple scanners and is a suitable method for image analysis in multicenter clinical trials.
在多中心环境中，使用计算机断层扫描肺动脉造影（CTPA）评估肺栓塞（PE）血栓体积定量的可重复性。
本研究使用符合《健康保险流通与责任法案》（HIPAA）和机构审查委员会（IRB）规定（2015年3月至2016年11月）的匿名数据。使用每个站点的标准PE方案，从18个影像中心的23台扫描仪获取匿名CTPA数据。两名独立分析人员在一个经美国食品药品监督管理局（FDA）批准的图像分析平台上，使用半自动区域生长算法测量PE体积。计算每位患者的总血栓体积（TTV）作为主要终点。次要终点是每位患者的单个血栓体积（ITV）、Qanadli评分和改良Qanadli评分。使用组内相关系数（ICC）和布兰德-奥特曼分析评估观察者间和观察者内的可重复性。
分析人员1在23例患者中发现72个栓子，每位患者的栓子平均数为3.13个，每位患者的栓子数范围为0 - 11个。血栓体积范围为0.0041 - 47.34 cm（均值±标准差，5.93±10.15 cm）。在第二次读取时，分析人员1发现栓子数量和分布相同，第二次读取的体积范围为0.0041 - 45.52 cm（均值±标准差，5.42±9.53 cm）。分析人员2在23例患者中发现73个栓子，每位患者的栓子平均数为3.17个，每位患者的栓子数范围为0 - 11个。血栓体积范围为0.00459 - 46.29 cm（均值±标准差，5.91±10.06 cm）。观察者间和观察者内变异性测量表明，半自动方法定量PE体积负荷具有出色的可重复性。观察者间和观察者内分析中，所有终点的ICC均大于0.95。布兰德-奥特曼分析表明无显著偏差。
使用来自多台扫描仪的数据，定量PE 的半自动区域生长算法具有可重复性，是多中心临床试验中一种合适的图像分析方法。
