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多中心临床试验背景下正常白质表观扩散系数值的扫描仪间及访视间差异

Between-Scanner and Between-Visit Variation in Normal White Matter Apparent Diffusion Coefficient Values in the Setting of a Multi-Center Clinical Trial.

作者信息

Huo J, Alger J, Kim H, Brown M, Okada K, Pope W, Goldin J

机构信息

TeraRecon Inc., 4000 E 3rd Ave., Suite 200, 94404, Foster City, CA, USA.

Department of Radiological Science, University of California in Los Angeles, 924 Westwood Blvd, Suite 650, 90024, Los Angeles, CA, USA.

出版信息

Clin Neuroradiol. 2016 Dec;26(4):423-430. doi: 10.1007/s00062-015-0381-3. Epub 2015 Mar 20.

Abstract

PURPOSE

To study the between-scanner variation and the between-visit reproducibility of brain apparent diffusion coefficient (ADC) measurements in the setting of a multi-center chemotherapy clinical trial for glioblastoma multiforme.

METHODS AND MATERIALS

ADC maps of 52 patients at six sites were calculated in-house from diffusion-weighted images obtained by seven individual scanner models of two vendors. The median and coefficient of variation (CV) of normal brain white matter ADC values from a defined region of interest were used to evaluate the differences among scanner models, vendors, magnetic fields, as well as successive visits. All patients participating in this study signed institutional review board approved informed consent. Data acquisition was performed in compliance with all applicable Health Insurance Portability and Accountability Act regulations. The study spanned from August 1, 2006, to January 29, 2008.

RESULTS

For baseline median ADC, no difference was observed between the different scanner models, different vendors, and different magnetic field strength. For baseline ADC CV, a significant difference was found between different scanner models (p = 0.0002). No between-scanner difference was observed in ADC changes between two visits. For between-visit reproducibility, significant difference was seen between the ADC values measured at two successive visits for the whole patient group.

CONCLUSION

The CVs varied significantly between scanners, presumably due to image noise. Consistent scanner parameter setup can improve reproducibility of the ADC measurements between visits.

摘要

目的

在多中心胶质母细胞瘤化疗临床试验背景下,研究脑部表观扩散系数(ADC)测量值在不同扫描仪之间的差异以及不同访视间的可重复性。

方法与材料

由两家供应商的七种不同扫描仪型号获取的扩散加权图像,在内部计算了六个研究点52例患者的ADC图。利用来自定义感兴趣区域的正常脑白质ADC值的中位数和变异系数(CV),评估扫描仪型号、供应商、磁场以及连续访视之间的差异。所有参与本研究的患者均签署了经机构审查委员会批准的知情同意书。数据采集符合所有适用的《健康保险流通与责任法案》规定。该研究从2006年8月1日持续至2008年1月29日。

结果

对于基线ADC中位数,不同扫描仪型号、不同供应商以及不同磁场强度之间未观察到差异。对于基线ADC的CV,不同扫描仪型号之间存在显著差异(p = 0.0002)。两次访视之间的ADC变化在不同扫描仪之间未观察到差异。对于访视间的可重复性,整个患者组在两次连续访视时测量的ADC值之间存在显著差异。

结论

不同扫描仪之间的CV差异显著,可能是由于图像噪声所致。一致的扫描仪参数设置可提高访视间ADC测量的可重复性。

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