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Quality assurance of quantitative cardiac T1-mapping in multicenter clinical trials - a T1 phantom program from the hypertrophic cardiomyopathy registry (HCMR) study

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Item Type:Article
Title:Quality assurance of quantitative cardiac T1-mapping in multicenter clinical trials - a T1 phantom program from the hypertrophic cardiomyopathy registry (HCMR) study
Creators Name:Zhang, Q. and Werys, K. and Popescu, I.A. and Biasiolli, L. and Ntusi, N.A.B. and Desai, M. and Zimmerman, S.L. and Shah, D.J. and Autry, K. and Kim, B. and Kim, H.W. and Jenista, E.R. and Huber, S. and White, J.A. and McCann, G.P. and Mohiddin, S.A. and Boubertakh, R. and Chiribiri, A. and Newby, D. and Prasad, S. and Radjenovic, A. and Dawson, D. and Schulz-Menger, J. and Mahrholdt, H. and Carbone, I. and Rimoldi, O. and Colagrande, S. and Calistri, L. and Michels, M. and Hofman, M.B.M. and Anderson, L. and Broberg, C. and Andrew, F. and Sanz, J. and Bucciarelli-Ducci, C. and Chow, K. and Higgins, D. and Broadbent, D.A. and Semple, S. and Hafyane, T. and Wormleighton, J. and Salerno, M. and He, T. and Plein, S. and Kwong, R.Y. and Jerosch-Herold, M. and Kramer, C.M. and Neubauer, S. and Ferreira, V.M. and Piechnik, S.K.
Abstract:BACKGROUND: Quantitative cardiovascular magnetic resonance T1-mapping is increasingly used for myocardial tissue characterization. However, the lack of standardization limits direct comparability between centers and wider roll-out for clinical use or trials. PURPOSE: To develop a quality assurance (QA) program assuring standardized T1 measurements for clinical use. METHODS: MR phantoms manufactured in 2013 were distributed, including ShMOLLI T1-mapping and reference T1 and T2 protocols. We first studied the T1 and T2 dependency on temperature and phantom aging using phantom datasets from a single site over 4 years. Based on this, we developed a multiparametric QA model, which was then applied to 78 scans from 28 other multi-national sites. RESULTS: Results: T1 temperature sensitivity followed a second-order polynomial to baseline T1 values (R(2) > 0.996). Some phantoms showed aging effects, where T1 drifted up to 49% over 40 months. The correlation model based on reference T1 and T2, developed on 1004 dedicated phantom scans, predicted ShMOLLI-T1 with high consistency (coefficient of variation 1.54%), and was robust to temperature variations and phantom aging. Using the 95% confidence interval of the correlation model residuals as the tolerance range, we analyzed 390 ShMOLLI T1-maps and confirmed accurate sequence deployment in 90%(70/78) of QA scans across 28 multiple centers, and categorized the rest with specific remedial actions. CONCLUSIONS: The proposed phantom QA for T1-mapping can assure correct method implementation and protocol adherence, and is robust to temperature variation and phantom aging. This QA program circumvents the need of frequent phantom replacements, and can be readily deployed in multicenter trials.
Keywords:Cardiac MRI, Quantitative T1-Mapping, Multicenter Study, Quality Assurance, Standardization, Phantom Study
Source:International Journal of Cardiology
ISSN:0167-5273
Publisher:Elsevier
Volume:330
Page Range:251-258
Date:1 May 2021
Official Publication:https://doi.org/10.1016/j.ijcard.2021.01.026
PubMed:View item in PubMed

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