Consensus recommendations for hyperpolarized [1‐ <scp> <sup>13</sup> C </scp> ]pyruvate <scp>MRI</scp> multi‐center human studies

MRI of hyperpolarized (HP) [1-<sup>13</sup>C]pyruvate allows in vivo assessment of metabolism and has translated into human studies across diseases at 15 centers worldwide. To determine consensus on best practice for multi-center studies for development of clinical applications. This paper presents the results of a two-round formal consensus building exercise carried out by experts with HP [1-<sup>13</sup>C]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-<sup>13</sup>C]pyruvate MRI. Overall, the group reached consensus on approximately two-thirds of 246 statements in the questionnaire, covering HP <sup>13</sup>C-pyruvate preparation; MRI system setup, calibration, and phantoms; acquisition and reconstruction; and data analysis and quantification. Consensus was present across categories. Examples include: (i) Different HP pyruvate preparation methods could be used in human studies, but the same release criteria have to be followed; (ii) site qualification and quality assurance must be performed with phantoms and the same field strength must be used, but 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 values and metabolite area under curve were the preferred metabolism metrics. The consensus proces revealed that HP[1-<sup>13</sup>C] pyruvate MRI as a technology has progressed sufficiently to plan multi-center studies. The work confirmed areas of consensus for multi-center study conduct and identified where further research is required to ascertain best practice.

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Journal
Magnetic Resonance in Medicine
Published
2025-06-16
DOI
https://doi.org/10.1002/mrm.30570
Citations
8
Primary Topic
Advanced NMR Techniques and Applications
Type
article
Field-Weighted Citation Impact
6.05

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article

Consensus recommendations for hyperpolarized [1‐ 13 C ]pyruvate MRI multi‐center human studies

Albert P. Chen, Jim Slater, Adam W. Autry, Vlad G. Zaha et al.
8 citations
Magnetic Resonance in Medicine
Advanced NMR Techniques and Applications
6.05
article

Consensus recommendations for hyperpolarized [1‐ 13 C ]pyruvate MRI multi‐center human studies

Albert P. Chen, Jim Slater, Adam W. Autry, Vlad G. Zaha, Kayvan R. Keshari, Damian J. Tyler, Jae Mo Park, Kozerke Sebastian, Duan Xu, Daniel B. Vigneron, Jan‐Bernd Hoevener, Peder E. Z. Larson, Richard L. Hesketh, Charles H. Cunningham, Arnaud Comment, Fulvio Zaccagna, Mary A. McLean, Rafat Chowdhury, Adam Gaunt, Robert Bok, Jeremy W. Gordon, Cornelius von Morze, Jan Henrik Ardenkjær‐Larsen, Shonit Punwani, Jean‐Luc Vanderheyden, Dirk Mayer, Mathilde H. Lerche, Esben Søvsø Szocska Hansen, Yanqing Gong, James T. Grist, James A. Bankson, Christoffer Laustsen, Titus Lanz, Lotte Bonde Bertelsen, Ashley Grimmer, Ching‐Yi Hsieh, Ferdia A. Gallagher, Jenna Bernard, Duy Dang, Jenny Che, Jan VanderMeulen
article en
8 citations

Abstract

MRI of hyperpolarized (HP) [1-<sup>13</sup>C]pyruvate allows in vivo assessment of metabolism and has translated into human studies across diseases at 15 centers worldwide. To determine consensus on best practice for multi-center studies for development of clinical applications. This paper presents the results of a two-round formal consensus building exercise carried out by experts with HP [1-<sup>13</sup>C]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-<sup>13</sup>C]pyruvate MRI. Overall, the group reached consensus on approximately two-thirds of 246 statements in the questionnaire, covering HP <sup>13</sup>C-pyruvate preparation; MRI system setup, calibration, and phantoms; acquisition and reconstruction; and data analysis and quantification. Consensus was present across categories. Examples include: (i) Different HP pyruvate preparation methods could be used in human studies, but the same release criteria have to be followed; (ii) site qualification and quality assurance must be performed with phantoms and the same field strength must be used, but 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 values and metabolite area under curve were the preferred metabolism metrics. The consensus proces revealed that HP[1-<sup>13</sup>C] pyruvate MRI as a technology has progressed sufficiently to plan multi-center studies. The work confirmed areas of consensus for multi-center study conduct and identified where further research is required to ascertain best practice.

Magnetic Resonance in MedicineVol. 94(4)
University of Maryland, Baltimore (US), Sunnybrook Health Science Centre (CA), Memorial Sloan Kettering Cancer Center (US), University College London Hospitals NHS Foundation Trust (GB), The University of Texas MD Anderson Cancer Center (US), The University of Texas at Dallas (US), Chang Gung University (TW), University of California, San Francisco (US), University of Toronto (CA), Aarhus University (DK), Washington University in St. Louis (US), University of Cambridge (GB), Buckinghamshire Healthcare NHS Trust (GB), Cancer Research UK (GB), Cambridge University Hospitals NHS Foundation Trust (GB), University of California System (US), Chang Gung Memorial Hospital (TW), Christian-Albrechts-Universität zu Kiel (DE), ETH Zurich (CH), University of Oxford (GB), London School of Hygiene & Tropical Medicine (GB), Institute for Biomedical Engineering (CH), University Hospital Schleswig-Holstein (DE), Advanced Imaging Research (United States) (US), Oxford University Hospitals NHS Trust (GB), RAPID Biomedical (Germany) (DE), Sunnybrook Research Institute, University College London (GB), The University of Texas Southwestern Medical Center (US), University of Lübeck (DE), Technical University of Denmark (DK)
Cancer Prevention and Research Institute of Texas, Aarhus Universitet, National Institute for Health and Care Research, Eidgenössische Technische Hochschule Zürich, Chang Gung Medical Foundation, National Institutes of Health, National Cancer Institute, National Institute of Biomedical Imaging and Bioengineering
Openalex Percentile: Top 3%
Advanced NMR Techniques and Applications
6.05
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