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

Qiang Zhang, Konrad Werys, Iulia A. Popescu, Luca Biasiolli, Ntobeko A.B. Ntusi, Milind Desai, Stefan L. Zimmerman, Dipan J. Shah, Kyle Autry, Bette Kim, Han W. Kim, Elizabeth R. Jenista, Steffen Huber, James A. White, Gerry P. McCann, Saidi A. Mohiddin, Redha Boubertakh, Amedeo Chiribiri, David Newby, Sanjay PrasadAleksandra Radjenovic, Dana Dawson, Jeanette Schulz-Menger, Heiko Mahrholdt, Iacopo Carbone, Ornella Rimoldi, Stefano Colagrande, Linda Calistri, Michelle Michels, Mark B.M. Hofman, Lisa Anderson, Craig Broberg, Flett Andrew, Javier Sanz, Chiara Bucciarelli-Ducci, Kelvin Chow, David Higgins, David A. Broadbent, Scott Semple, Tarik Hafyane, Joanne Wormleighton, Michael Salerno, Taigang He, Sven Plein, Raymond Y. Kwong, Michael Jerosch-Herold, Christopher M. Kramer, Stefan Neubauer, Vanessa M. Ferreira, Stefan K. Piechnik

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)251-258
Number of pages8
JournalInternational Journal of Cardiology
Volume330
DOIs
StatePublished - May 1 2021

Keywords

  • Cardiac MRI
  • Multicenter study
  • Phantom study
  • Quality assurance
  • Quantitative T1-mapping
  • Standardization

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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