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[Preprint]. 2025 Apr 29:arXiv:2504.20440v1.

Consensus Recommendations for Hyperpolarized [1-¹³C]pyruvate MRI Multi-center Human Studies

Shonit Punwani^{1

2}, Peder Ez Larson³, Christoffer Laustsen⁴, Jan VanderMeulen⁵, Jan Henrik Ardenkjær-Larsen⁶, Adam W Autry³, James A Bankson⁷, Jenna Bernard³, Robert Bok³, Lotte Bonde Bertelsen⁴, Jenny Che³, Albert P Chen⁸, Rafat Chowdhury^{1

2}, Arnaud Comment⁹, Charles H Cunningham^{10

11}, Duy Dang³, Ferdia A Gallagher¹², Adam Gaunt¹³, Yangcan Gong^{1

2}, Jeremy W Gordon³, Ashley Grimmer¹², James Grist^{14

15}, Esben Søvsø Szocska Hansen⁴, Mathilde Hauge Lerche⁶, Richard L Hesketh¹⁶, Jan-Bernd Hoevener¹⁷, Ching-Yi Hsieh¹⁸, Kayvan R Keshari¹⁹, Sebastian Kozerke²⁰, Titus Lanz²¹, Dirk Mayer^{22

23}, Mary McLean^{12

24}, Jae Mo Park^{25

26

27}, Jim Slater³, Damian Tyler^{14

28

15}, Jean-Luc Vanderheyden^{29

30}, Cornelius von Morze³¹, Fulvio Zaccagna^{12

14

32

33

34}, Vlad Zaha^{25

35}, Duan Xu³, Daniel Vigneron³; HP 13C MRI Consensus Group

Affiliations

¹ Department of Radiology, University College London Hospital NHS Foundation Trust, London, UK.
² Centre for Medical Imaging, University College London, London, UK.
³ Department of Radiology and Biomedical Imaging, University of California, San Francisco, CA 94143, USA.
⁴ The MR Research Center, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
⁵ Department of Health Services Research & Policy, London School of Hygiene & Tropical Medicine, London, UK.
⁶ Department of Health Technology, Technical University of Denmark,2800, Kgs. Lyngby, Denmark.
⁷ Department of Imaging Physics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
⁸ GE Healthcare, Toronto, Ontario, Canada.
⁹ GE HealthCare, Pollards Wood, Nightingales Lane, Chalfont St Giles, Buckinghamshire HP8 4SP, United Kingdom.
¹⁰ Physical Sciences, Sunnybrook Research Institute, Toronto, Ontario, Canada.
¹¹ Department of Medical Biophysics, University of Toronto, Toronto, Ontario, Canada.
¹² Department of Radiology, University of Cambridge and Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
¹³ GE Healthcare, San Francisco, California, USA.
¹⁴ Oxford Centre for Clinical Magnetic Resonance Research, University of Oxford, Oxford, UK.
¹⁵ Department of Radiology, Oxford University Hospitals, Oxford, UK.
¹⁶ Cancer Research UK Cambridge Institute, University of Cambridge, Cambridge, United Kingdom.
¹⁷ Department for Radiology and Neuroradiology, Molecular Imaging North Competence Center (MOIN CC), Section Biomedical Imaging, University Hospital Schleswig-Holstein - Campus Kiel, Kiel University, Germany.
¹⁸ Research Center for Radiation Medicine, Chang Gung University, Taoyuan, Taiwan, and Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital at Linkou, Taoyuan, Taiwan.
¹⁹ Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Molecular Pharmacology Program, Memorial Sloan Kettering Cancer Center, New York, NY,USA.
²⁰ Institute for Biomedical Engineering, University and ETH Zurich, Zurich, Switzerland.
²¹ RAPID Biomedical GmbH, 97222 Rimpar, Germany.
²² Department of Diagnostic Radiology and Nuclear Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.
²³ University of Maryland Marlene and Stewart Comprehensive Cancer Center, Baltimore, Maryland, USA.
²⁴ Cancer Research UK Cambridge Institute, University of Cambridge, Cambridge, UK.
²⁵ Advanced Imaging Research Center, The University of Texas Southwestern Medical Center, Dallas, Texas, USA.
²⁶ Radiology, The University of Texas Southwestern Medical Center, Dallas, Texas, USA.
²⁷ Electrical and Computer Engineering, The University of Texas at Dallas, Richardson, Texas, USA.
²⁸ Department of Physiology, Anatomy, and Genetics, University of Oxford, Oxford, UK.
²⁹ GE Healthcare, Menlo Park, California, USA.
³⁰ JLVMI Consulting LLC, Dousman, WI, USA.
³¹ Department of Radiology, Washington University, St. Louis, Missouri, USA.
³² Department of Medicine, University of Cambridge, United Kingdom.
³³ Department of Imaging, Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Cambridge, United Kingdom.
³⁴ Investigative Medicine Division, Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom.
³⁵ Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, Texas, USA.

PMID: 40342865
PMCID: PMC12060990

Consensus Recommendations for Hyperpolarized [1-¹³C]pyruvate MRI Multi-center Human Studies

Shonit Punwani et al. ArXiv. 2025.

[Preprint]. 2025 Apr 29:arXiv:2504.20440v1.

Authors

Affiliations

¹ Department of Radiology, University College London Hospital NHS Foundation Trust, London, UK.
² Centre for Medical Imaging, University College London, London, UK.
³ Department of Radiology and Biomedical Imaging, University of California, San Francisco, CA 94143, USA.
⁴ The MR Research Center, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
⁵ Department of Health Services Research & Policy, London School of Hygiene & Tropical Medicine, London, UK.
⁶ Department of Health Technology, Technical University of Denmark,2800, Kgs. Lyngby, Denmark.
⁷ Department of Imaging Physics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
⁸ GE Healthcare, Toronto, Ontario, Canada.
⁹ GE HealthCare, Pollards Wood, Nightingales Lane, Chalfont St Giles, Buckinghamshire HP8 4SP, United Kingdom.
¹⁰ Physical Sciences, Sunnybrook Research Institute, Toronto, Ontario, Canada.
¹¹ Department of Medical Biophysics, University of Toronto, Toronto, Ontario, Canada.
¹² Department of Radiology, University of Cambridge and Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
¹³ GE Healthcare, San Francisco, California, USA.
¹⁴ Oxford Centre for Clinical Magnetic Resonance Research, University of Oxford, Oxford, UK.
¹⁵ Department of Radiology, Oxford University Hospitals, Oxford, UK.
¹⁶ Cancer Research UK Cambridge Institute, University of Cambridge, Cambridge, United Kingdom.
¹⁷ Department for Radiology and Neuroradiology, Molecular Imaging North Competence Center (MOIN CC), Section Biomedical Imaging, University Hospital Schleswig-Holstein - Campus Kiel, Kiel University, Germany.
¹⁸ Research Center for Radiation Medicine, Chang Gung University, Taoyuan, Taiwan, and Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital at Linkou, Taoyuan, Taiwan.
¹⁹ Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Molecular Pharmacology Program, Memorial Sloan Kettering Cancer Center, New York, NY,USA.
²⁰ Institute for Biomedical Engineering, University and ETH Zurich, Zurich, Switzerland.
²¹ RAPID Biomedical GmbH, 97222 Rimpar, Germany.
²² Department of Diagnostic Radiology and Nuclear Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.
²³ University of Maryland Marlene and Stewart Comprehensive Cancer Center, Baltimore, Maryland, USA.
²⁴ Cancer Research UK Cambridge Institute, University of Cambridge, Cambridge, UK.
²⁵ Advanced Imaging Research Center, The University of Texas Southwestern Medical Center, Dallas, Texas, USA.
²⁶ Radiology, The University of Texas Southwestern Medical Center, Dallas, Texas, USA.
²⁷ Electrical and Computer Engineering, The University of Texas at Dallas, Richardson, Texas, USA.
²⁸ Department of Physiology, Anatomy, and Genetics, University of Oxford, Oxford, UK.
²⁹ GE Healthcare, Menlo Park, California, USA.
³⁰ JLVMI Consulting LLC, Dousman, WI, USA.
³¹ Department of Radiology, Washington University, St. Louis, Missouri, USA.
³² Department of Medicine, University of Cambridge, United Kingdom.
³³ Department of Imaging, Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Cambridge, United Kingdom.
³⁴ Investigative Medicine Division, Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom.
³⁵ Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, Texas, USA.

PMID: 40342865
PMCID: PMC12060990

Update in

Consensus recommendations for hyperpolarized [1-¹³C]pyruvate MRI multi-center human studies.
Punwani S, Larson PEZ, Laustsen C, VanderMeulen J, Ardenkjær-Larsen JH, Autry AW, Bankson JA, Bernard J, Bok R, Bertelsen LB, Che J, Chen AP, Chowdhury R, Comment A, Cunningham CH, Dang D, Gallagher FA, Gaunt A, Gong Y, Gordon JW, Grimmer A, Grist J, Hansen ESS, Lerche MH, Hesketh RL, Hoevener JB, Hsieh CY, Keshari KR, Kozerke S, Lanz T, Mayer D, McLean M, Park JM, Slater J, Tyler D, Vanderheyden JL, von Morze C, Zaccagna F, Zaha V, Xu D, Vigneron D; HP 13C MRI Consensus Group. Punwani S, et al. Magn Reson Med. 2025 Oct;94(4):1386-1400. doi: 10.1002/mrm.30570. Epub 2025 Jun 16. Magn Reson Med. 2025. PMID: 40523079 Free PMC article.

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.

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Conflict of interest statement

DV, PL, and JG receive research grant funding from GE Healthcare. DV, RB, JS and SP are advisors for NVision Imaging Technologies. JAB is on the scientific advisory board for NVision, and he receives research funding from Siemens. JHA is the owner of Polarize, a company that sells instrumentation for hyperpolarization. FG receives research support from GE Healthcare and grant funding from NVision and AstraZeneca. KRK is a founder of Atish Technologies and a member of the scientific advisory boards of Nvision Imaging Technologies, Imaginostics and Mi2. KRK hold patents related to imaging and modulation of cellular metabolism. SP is an advisor for QUIBIM Ltd, and Cheif Medical Officer for Gold Standard Phantoms. CV receives research support from Siemens.

Figures

**Figure 1:**
Illustration of the HP [1–¹³C]pyruvate MRI human study process, including the 4 major areas covered in this paper: Hyperpolarized [1–¹³C]pyruvate preparation, MRI system setup and calibration, Acquisition and Reconstruction, and Data Analysis and Quantification.

See this image and copyright information in PMC

References

1. Nelson SJ, Kurhanewicz J, Vigneron DB, et al. Metabolic Imaging of Patients with Prostate Cancer Using Hyperpolarized [1–13C]Pyruvate. Sci Transl Med. 2013;5(198):198ra108. doi: 10.1126/scitranslmed.3006070 - DOI - PMC - PubMed
1. Larson PEZ, Bernard JML, Bankson JA, et al. Current methods for hyperpolarized [1-C]pyruvate MRI human studies. Magnetic Resonance in Medicine. 2024;91(6):2204–2228. doi: 10.1002/mrm.29875 - DOI - PMC - PubMed
1. Hubbard Cristinacce PL, Markus JE, Punwani S, et al. Steps on the Path to Clinical Translation: A workshop by the British and Irish Chapter of the ISMRM. Magn Reson Med. 2023;90(3):1130–1136. doi: 10.1002/mrm.29704 - DOI - PubMed
1. O’Connor JPB, Aboagye EO, Adams JE, et al. Imaging biomarker roadmap for cancer studies. Nat Rev Clin Oncol. 2017;14(3):169–186. doi: 10.1038/nrclinonc.2016.162 - DOI - PMC - PubMed
1. Fitch K, Bernstein SJ, Aguilar MD, et al. The RAND/UCLA Appropriateness Method User’s Manual. RAND Corporation; 2001.

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This is a preprint.

Consensus Recommendations for Hyperpolarized [1-¹³C]pyruvate MRI Multi-center Human Studies

Affiliations

Consensus Recommendations for Hyperpolarized [1-¹³C]pyruvate MRI Multi-center Human Studies

Authors

Affiliations

Update in

Abstract

Conflict of interest statement

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References

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