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 (1.0×0.31×0.31 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.
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Competing interests: FE is CEO of Chondrometrics GmbH, a company providing MRI analysis services. FE provides consulting services to Pfizer, MerckSerono, AstraZeneca and Wyeth. RJB is employed by Pfizer Inc. DB receives grant support from Pfizer, Stryker, Gelita and Genzyme. HCC receives grant support from Pfizer. JC receives grant support from Pfizer. MH has a part-time appointment with Chondrometrics GmbH. DJH receives grant support from Pfizer, Merck and DonJoy. GH receives grant support from Pfizer. CJ receives research grants from Pfizer. VBK receives research grants from Pfizer. TML receives research grants from Pfizer, GlaxoSmithKline and Merck. SMaj receives research grants from Pfizer. SMaz receives grant support from, and provides consulting services to, Pfizer Inc. PVP receives research grants from Pfizer. TJS receives research grants from Pfizer. MST receives research grants from Pfizer. AV receives research grants from Pfizer. BW is employed by Pfizer Inc. M-PHLeG is employed by Pfizer Inc.
Funding: Funding was provided by Pfizer Inc.
Ethics approval: The study was conducted in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with local Institutional Review Board, informed consent regulations and International Conference on Harmonization Good Clinical Practices Guidelines.