1. Quality assurance of quantitative cardiac T1-mapping in multicenter clinical trials – A T1 phantom program from the hypertrophic cardiomyopathy registry (HCMR) study
- Author
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Dipan J. Shah, Han W. Kim, Michael Salerno, Bette Kim, Aleksandra Radjenovic, Milind Y. Desai, Iulia A. Popescu, Sven Plein, David M. Higgins, Tarik Hafyane, Michelle Michels, Stefan K. Piechnik, Kyle Autry, Kelvin Chow, Christopher M. Kramer, Stefan L. Zimmerman, James A. White, Ntobeko A B Ntusi, Taigang He, Dana Dawson, Craig S. Broberg, Ornella Rimoldi, Linda Calistri, Amedeo Chiribiri, Chiara Bucciarelli-Ducci, Steffen Huber, Lisa M Anderson, Mark B.M. Hofman, Sanjay K Prasad, Joanne Wormleighton, Qiang Zhang, Stefano Colagrande, Flett Andrew, Michael Jerosch-Herold, Luca Biasiolli, Elizabeth R. Jenista, Konrad Werys, Iacopo Carbone, Heiko Mahrholdt, Javier Sanz, Raymond Y. Kwong, Jeanette Schulz-Menger, Redha Boubertakh, Saidi A Mohiddin, David A. Broadbent, Gerry P McCann, Scott Semple, David E. Newby, Vanessa M Ferreira, Stefan Neubauer, Cardiology, Radiology and nuclear medicine, ACS - Atherosclerosis & ischemic syndromes, and ACS - Heart failure & arrhythmias
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Magnetic Resonance Spectroscopy ,Coefficient of variation ,Phantom study ,030204 cardiovascular system & hematology ,Imaging phantom ,Article ,03 medical and health sciences ,0302 clinical medicine ,medicine ,Humans ,030212 general & internal medicine ,Quantitative T1-mapping ,Registries ,Cardiac MRI ,Protocol (science) ,medicine.diagnostic_test ,business.industry ,Phantoms, Imaging ,Hypertrophic cardiomyopathy ,Reproducibility of Results ,Magnetic resonance imaging ,Cardiomyopathy, Hypertrophic ,Reference Standards ,medicine.disease ,Magnetic Resonance Imaging ,Confidence interval ,Multicenter study ,Quality assurance ,Standardization ,Clinical trial ,Cardiovascular and Metabolic Diseases ,Cardiology and Cardiovascular Medicine ,Nuclear medicine ,business - 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 T1 temperature sensitivity followed a second-order polynomial to baseline T1 values (R2 > 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., Highlights • CMR T1 correlated with reference T1 and T2; this derives the QA model for T1-map. • The proposed QA model is robust to temperature variations and phantom aging. • This QA method requires no frequent phantom replacements. • The T1-map QA program can be readily deployed in multicenter trials.
- Published
- 2021
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