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多中心临床试验中3.0特斯拉定量磁共振成像对软骨形态的精准度

Precision of 3.0 Tesla quantitative magnetic resonance imaging of cartilage morphology in a multicentre clinical trial.

作者信息

Eckstein F, Buck R J, Burstein D, Charles H C, Crim J, Hudelmaier M, Hunter D J, Hutchins G, Jackson C, Kraus V Byers, Lane N E, Link T M, Majumdar L S, Mazzuca S, Prasad P V, Schnitzer T J, Taljanovic M S, Vaz A, Wyman B, Le Graverand M-P Hellio

机构信息

Institute of Anatomy and Musculoskeletal Research, PMU, Strubergasse 21, A5020 Salzburg Austria.

出版信息

Ann Rheum Dis. 2008 Dec;67(12):1683-8. doi: 10.1136/ard.2007.076919. Epub 2008 Feb 18.

Abstract

OBJECTIVE

Quantitative MRI (qMRI) of cartilage morphology is a promising tool for disease-modifying osteoarthritis drug (DMOAD) development. Recent studies at single sites have indicated that measurements at 3.0 Tesla (T) are more reproducible (precise) than those at 1.5 T. Precision errors and stability in multicentre studies with imaging equipment from various vendors have, however, not yet been evaluated.

METHODS

A total of 158 female participants (97 Kellgren and Lawrence grade (KLG) 0, 31 KLG 2 and 30 KLG 3) were imaged at 7 clinical centres using Siemens Magnetom Trio and GE Signa Excite magnets. Double oblique coronal acquisitions were obtained at baseline and at 3 months, using water excitation spoiled gradient echo sequences (1.0x0.31x0.31 mm3 resolution). Segmentation of femorotibial cartilage morphology was performed using proprietary software (Chondrometrics GmbH, Ainring, Germany).

RESULTS

The precision error (root mean square coefficient of variation (RMS CV)%) for cartilage thickness/volume measurements ranged from 2.1%/2.4% (medial tibia) to 2.9%/3.3% (lateral weight-bearing femoral condyle) across all participants. No significant differences in precision errors were observed between KLGs, imaging sites, or scanner manufacturers/types. Mean differences between baseline and 3 months ranged from <0.1% (non-significant) in the medial to 0.94% (p<0.01) in the lateral femorotibial compartment, and were 0.33% (p<0.02) for the total femorotibial subchondral bone area.

CONCLUSIONS

qMRI performed at 3.0 T provides highly reproducible measurements of cartilage morphology in multicentre clinical trials with equipment from different vendors. The technology thus appears sufficiently robust to be recommended for large-scale multicentre trials.

摘要

目的

软骨形态定量磁共振成像(qMRI)是一种很有前景的用于开发改善病情的骨关节炎药物(DMOAD)的工具。近期在单中心开展的研究表明,3.0特斯拉(T)磁场下的测量结果比1.5T磁场下的测量结果更具可重复性(更精确)。然而,在多中心研究中,使用不同厂商成像设备时的精度误差和稳定性尚未得到评估。

方法

共有158名女性参与者(97名凯尔格伦和劳伦斯分级(KLG)为0级,31名KLG为2级,30名KLG为3级)在7个临床中心使用西门子Magnetom Trio和通用电气Signa Excite磁共振成像仪进行成像。在基线期和3个月时采用水激发扰相梯度回波序列(分辨率为1.0×0.31×0.31mm³)进行双斜冠状面采集。使用专用软件(德国艾恩林的Chondrometrics GmbH公司)对股胫软骨形态进行分割。

结果

在所有参与者中,软骨厚度/体积测量的精度误差(均方根变异系数(RMS CV)%)范围为2.1%/2.4%(胫骨内侧)至2.9%/3.3%(外侧负重股骨髁)。在KLG分级、成像地点或扫描仪制造商/类型之间,未观察到精度误差有显著差异。基线期和3个月时的平均差异在内侧为<0.1%(无显著性差异),在股胫外侧间室为0.94%(p<0.01),股胫软骨下骨总面积的平均差异为0.33%(p<0.02)。

结论

在多中心临床试验中,使用不同厂商设备在3.0T磁场下进行的qMRI能够提供高度可重复的软骨形态测量结果。因此,这项技术似乎足够可靠,可推荐用于大规模多中心试验。

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