. 2025 Oct;94(4):1386-1400.

doi: 10.1002/mrm.30570. Epub 2025 Jun 16.

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

Shonit Punwani^{1

2}, Peder E Z 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 Hsieh^{18

19}, Kayvan R Keshari^{20

21}, Sebastian Kozerke²², Titus Lanz²³, Dirk Mayer^{24

25}, Mary McLean^{12

16}, Jae Mo Park^{26

27

28}, Jim Slater³, Damian Tyler^{14

15

29}, Jean-Luc Vanderheyden^{30

31}, Cornelius von Morze³², Fulvio Zaccagna^{11

14

33

34

35}, Vlad Zaha^{24

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

Collaborators, Affiliations

Collaborators

HP 13C MRI Consensus Group:
Lotte Bonde Bertelsen, Nikolaj Bøgh, Esben Søvsø Szocska Hansen, Christoffer Laustsen, Jack Miller, Michael Vaeggemose, Jonas Steinhauser, Ching-Yi Hsieh, Gigin Lin, Max Fuetterer, Sebastian Kozerke, Albert Chen, Arnaud Comment, Adam Gaunt, Justin Lau, Avi Leftin, Rolf Schulte, Jean-Luc Vanderheyden, Irene Marco Rius, Jan-Bernd Hoevener, Thomas C Booth, Mor Mishkovsky, Christopher Michael Walker, Jim Bankson, Kayvan Keshari, Ramona Woitek, Yuhei Takado, Crystal Vasquez, Sebastien Serres, Christoph A Müller, Joel Floyd, Titus Lanz, Jan Henrik Ardenkjær-Larsen, Andrea Capozzi, Mathilde Hauge Lerche, Martin Grashei, Franz Schilling, Geoffrey J Topping, Frits van Heijster, Adam Autry, Jenna Bernard, Bob Bok, Myriam Chaumeil, Jenny Che, Duy Dang, Jeremy Gordon, Yaewon Kim, John Kurhanewicz, Peder Larson, Yan Li, Michael Ohliger, Jim Slater, Renuka Sriram, Dan Vigneron, Zhen Jane Wang, Duan Xu, Ashley Grimmer, Mary McLean, Fulvio Zaccagna, Ferdia Gallagher, Rafat Chowdhury, Yangcan Gong, Shonit Punwani, Richard Hesketh, Jeraj Hassan, Andreas Kjaer, Matthew Merritt, Michael Bock, Andreas Schmidt, Dirk Mayer, Myounghee Lee, James Grist, Damian Tyler, Sarah Birkhoelzer, Jordan McGing, Aaron Axford, Oliver Rider, Fatemeh Khashami, Craig Malloy, Jae Mo Park, Vlad Zaha, Sung-Han Lin, Junjie Ma, Charles Cunningham, Cornelius von Morze

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, California, 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, Kgs. Lyngby, Denmark.
⁷ Department of Imaging Physics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
⁸ GE Healthcare, Toronto, Ontario, Canada.
⁹ GE HealthCare, Pollards Wood, Nightingales Lane, Chalfont St Giles, Buckinghamshire, UK.
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, UK.
¹⁷ Department for Radiology and Neuroradiology, Molecular Imaging North Competence Center (MOIN CC), Section Biomedical Imaging, University Hospital Schleswig-Holstein - Campus Kiel, Kiel University, Kiel, Germany.
¹⁸ Research Center for Radiation Medicine, Chang Gung University, Taoyuan, Taiwan.
¹⁹ Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital at Linkou, Taoyuan, Taiwan.
²⁰ Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
²¹ Molecular Pharmacology Program, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
²² Institute for Biomedical Engineering, University and ETH Zurich, Zurich, Switzerland.
²³ RAPID Biomedical GmbH, Rimpar, Germany.
²⁴ Department of Diagnostic Radiology and Nuclear Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.
²⁵ University of Maryland Marlene and Stewart Comprehensive Cancer Center, Baltimore, Maryland, USA.
²⁶ Advanced Imaging Research Center, The University of Texas Southwestern Medical Center, Dallas, Texas, USA.
²⁷ Radiology, The University of Texas Southwestern Medical Center, Dallas, Texas, USA.
²⁸ Electrical and Computer Engineering, The University of Texas at Dallas, Richardson, Texas, USA.
²⁹ Department of Physiology, Anatomy, and Genetics, University of Oxford, Oxford, UK.
³⁰ GE Healthcare, Menlo Park, California, USA.
³¹ JLVMI Consulting LLC, Dousman, Wisconsin, USA.
³² Department of Radiology, Washington University, St. Louis, Missouri, USA.
³³ Department of Medicine, University of Cambridge, Cambridge, UK.
³⁴ Department of Imaging, Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Cambridge, UK.
³⁵ Investigative Medicine Division, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.
³⁶ Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, Texas, USA.

PMID: 40523079
PMCID: PMC12236423
DOI: 10.1002/mrm.30570

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

Shonit Punwani et al. Magn Reson Med. 2025 Oct.

. 2025 Oct;94(4):1386-1400.

doi: 10.1002/mrm.30570. Epub 2025 Jun 16.

Authors

Collaborators

HP 13C MRI Consensus Group:
Lotte Bonde Bertelsen, Nikolaj Bøgh, Esben Søvsø Szocska Hansen, Christoffer Laustsen, Jack Miller, Michael Vaeggemose, Jonas Steinhauser, Ching-Yi Hsieh, Gigin Lin, Max Fuetterer, Sebastian Kozerke, Albert Chen, Arnaud Comment, Adam Gaunt, Justin Lau, Avi Leftin, Rolf Schulte, Jean-Luc Vanderheyden, Irene Marco Rius, Jan-Bernd Hoevener, Thomas C Booth, Mor Mishkovsky, Christopher Michael Walker, Jim Bankson, Kayvan Keshari, Ramona Woitek, Yuhei Takado, Crystal Vasquez, Sebastien Serres, Christoph A Müller, Joel Floyd, Titus Lanz, Jan Henrik Ardenkjær-Larsen, Andrea Capozzi, Mathilde Hauge Lerche, Martin Grashei, Franz Schilling, Geoffrey J Topping, Frits van Heijster, Adam Autry, Jenna Bernard, Bob Bok, Myriam Chaumeil, Jenny Che, Duy Dang, Jeremy Gordon, Yaewon Kim, John Kurhanewicz, Peder Larson, Yan Li, Michael Ohliger, Jim Slater, Renuka Sriram, Dan Vigneron, Zhen Jane Wang, Duan Xu, Ashley Grimmer, Mary McLean, Fulvio Zaccagna, Ferdia Gallagher, Rafat Chowdhury, Yangcan Gong, Shonit Punwani, Richard Hesketh, Jeraj Hassan, Andreas Kjaer, Matthew Merritt, Michael Bock, Andreas Schmidt, Dirk Mayer, Myounghee Lee, James Grist, Damian Tyler, Sarah Birkhoelzer, Jordan McGing, Aaron Axford, Oliver Rider, Fatemeh Khashami, Craig Malloy, Jae Mo Park, Vlad Zaha, Sung-Han Lin, Junjie Ma, Charles Cunningham, Cornelius von Morze

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, California, 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, Kgs. Lyngby, Denmark.
⁷ Department of Imaging Physics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
⁸ GE Healthcare, Toronto, Ontario, Canada.
⁹ GE HealthCare, Pollards Wood, Nightingales Lane, Chalfont St Giles, Buckinghamshire, UK.
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, UK.
¹⁷ Department for Radiology and Neuroradiology, Molecular Imaging North Competence Center (MOIN CC), Section Biomedical Imaging, University Hospital Schleswig-Holstein - Campus Kiel, Kiel University, Kiel, Germany.
¹⁸ Research Center for Radiation Medicine, Chang Gung University, Taoyuan, Taiwan.
¹⁹ Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital at Linkou, Taoyuan, Taiwan.
²⁰ Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
²¹ Molecular Pharmacology Program, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
²² Institute for Biomedical Engineering, University and ETH Zurich, Zurich, Switzerland.
²³ RAPID Biomedical GmbH, Rimpar, Germany.
²⁴ Department of Diagnostic Radiology and Nuclear Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.
²⁵ University of Maryland Marlene and Stewart Comprehensive Cancer Center, Baltimore, Maryland, USA.
²⁶ Advanced Imaging Research Center, The University of Texas Southwestern Medical Center, Dallas, Texas, USA.
²⁷ Radiology, The University of Texas Southwestern Medical Center, Dallas, Texas, USA.
²⁸ Electrical and Computer Engineering, The University of Texas at Dallas, Richardson, Texas, USA.
²⁹ Department of Physiology, Anatomy, and Genetics, University of Oxford, Oxford, UK.
³⁰ GE Healthcare, Menlo Park, California, USA.
³¹ JLVMI Consulting LLC, Dousman, Wisconsin, USA.
³² Department of Radiology, Washington University, St. Louis, Missouri, USA.
³³ Department of Medicine, University of Cambridge, Cambridge, UK.
³⁴ Department of Imaging, Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Cambridge, UK.
³⁵ Investigative Medicine Division, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.
³⁶ Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, Texas, USA.

PMID: 40523079
PMCID: PMC12236423
DOI: 10.1002/mrm.30570

Abstract

MRI of hyperpolarized (HP) [1-¹³C]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 [1-¹³C]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: (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[1-¹³C] 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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Conflict of interest statement

d.v., p.l., and j.g. receive research grant funding from GE Healthcare. d.v., r.b., j.s., and s.p. are advisors for NVision Imaging Technologies. j.a.b is on the scientific advisory board for NVision and receives research funding from Siemens. j.h.a. is the owner of Polarize, a company that sells instrumentation for hyperpolarization. f.g. receives research support from GE Healthcare and grant funding from NVision and AstraZeneca. k.r.k. is a founder of Atish Technologies and a member of the scientific advisory boards of Nvision Imaging Technologies, Imaginostics, and Mi2. k.r.k. hold patents related to imaging and modulation of cellular metabolism. s.p. is an advisor for QUIBIM Ltd. and chief medical officer for Gold Standard Phantoms. c.v. receives research support from Siemens.

Figures

**FIGURE 1**
Illustration of the HP [1‐¹³C]pyruvate MRI human study process, including the four major areas covered in this paper: HP [1‐¹³C]pyruvate preparation; MRI system setup, calibration, and phantoms; acquisition and reconstruction; and data analysis and quantification.

See this image and copyright information in PMC

Update of

Consensus Recommendations for Hyperpolarized [1-¹³C]pyruvate MRI Multi-center Human Studies.
Punwani S, Larson PE, 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. ArXiv [Preprint]. 2025 Apr 29:arXiv:2504.20440v1. ArXiv. 2025. Update in: Magn Reson Med. 2025 Oct;94(4):1386-1400. doi: 10.1002/mrm.30570. PMID: 40342865 Free PMC article. Updated. Preprint.

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;5:198ra108. - PMC - PubMed
1. Larson PEZ, Bernard JML, Bankson JA, et al. Current methods for hyperpolarized [1‐C]pyruvate MRI human studies. Magn Reson Med. 2024;91:2204‐2228. - PMC - PubMed
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Consensus recommendations for hyperpolarized [1-¹³C]pyruvate MRI multi-center human studies

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

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