Consensus Recommendations for Hyperpolarized [1-13C]pyruvate MRI Multi-center Human Studies
Abstract
Magnetic resonance imaging of hyperpolarized (HP) [1-13C]pyruvate allows in-vivo assessment of metabolism and has translated into human studies across diseases at 15 centers worldwide. Consensus on best practice for multi-center studies is required to develop clinical applications. This paper presents the results of a 2-round formal consensus building exercise carried out by experts with HP [1-13C]pyruvate human study experience. Twenty-nine participants from 13 sites brought together expertise in pharmacy methods, MR physics, translational imaging, and data-analysis; with the goal of providing recommendations and best practice statements on conduct of multi-center human studies of HP [1-13C]pyruvate MRI. Overall, the group reached consensus on approximately two-thirds of 246 statements in the questionnaire, covering 'HP 13C-Pyruvate Preparation', 'MRI System Setup, Calibration, and Phantoms', 'Acquisition and Reconstruction', and 'Data Analysis and Quantification'. Consensus was present across categories, examples include that: (i) different HP pyruvate preparation methods could be used in human studies, but that the same release criteria have to be followed; (ii) site qualification and quality assurance must be performed with phantoms and that the same field strength must be used, but that the rest of the system setup and calibration methods could be determined by individual sites; (iii) the same pulse sequence and reconstruction methods were preferable, but the exact choice should be governed by the anatomical target; (iv) normalized metabolite area-under-curve (AUC) values and metabolite AUC were the preferred metabolism metrics. The work confirmed areas of consensus for multi-center study conduct and identified where further research is required to ascertain best practice.
Cite
@article{arxiv.2504.20440,
title = {Consensus Recommendations for Hyperpolarized [1-13C]pyruvate MRI Multi-center Human Studies},
author = {Shonit Punwani and Peder EZ Larson and Christoffer Laustsen and Jan VanderMeulen and Jan Henrik Ardenkjær-Larsen and Adam W. Autry and James A. Bankson and Jenna Bernard and Robert Bok and Lotte Bonde Bertelsen and Jenny Che and Albert P. Chen and Rafat Chowdhury and Arnaud Comment and Charles H. Cunningham and Duy Dang and Ferdia A Gallagher and Adam Gaunt and Yangcan Gong and Jeremy W. Gordon and Ashley Grimmer and James Grist and Esben Søvsø Szocska Hansen and Mathilde Hauge Lerche and Richard L. Hesketh and Jan-Bernd Hoevener and Ching-Yi Hsieh and Kayvan R. Keshari and Sebastian Kozerke and Titus Lanz and Dirk Mayer and Mary McLean and Jae Mo Park and Jim Slater and Damian Tyler and Jean-Luc Vanderheyden and Daniel Vigneron and Cornelius von Morze and Duan Xu and Fulvio Zaccagna and Vlad Zaha and the HP 13C MRI Consensus Group},
journal= {arXiv preprint arXiv:2504.20440},
year = {2025}
}