发布日期: 2025-05-01

更新日期: 2025-05-04

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2025-05-01 更新

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

Authors:Shonit Punwani, Peder EZ Larson, Christoffer Laustsen, Jan VanderMeulen, Jan Henrik Ardenkjær-Larsen, Adam W. Autry, James A. Bankson, Jenna Bernard, Robert Bok, Lotte Bonde Bertelsen, Jenny Che, Albert P. Chen, Rafat Chowdhury, Arnaud Comment, Charles H. Cunningham, Duy Dang, Ferdia A Gallagher, Adam Gaunt, Yangcan Gong, Jeremy W. Gordon, Ashley Grimmer, James Grist, Esben Søvsø Szocska Hansen, Mathilde Hauge Lerche, Richard L. Hesketh, Jan-Bernd Hoevener, Ching-Yi Hsieh, Kayvan R. Keshari, Sebastian Kozerke, Titus Lanz, Dirk Mayer, Mary McLean, Jae Mo Park, Jim Slater, Damian Tyler, Jean-Luc Vanderheyden, Daniel Vigneron, Cornelius von Morze, Duan Xu, Fulvio Zaccagna, Vlad Zaha, the HP 13C MRI Consensus Group

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.

极化（HP）[1-13C]丙酮酸盐的磁共振成像允许对体内代谢进行评估，并已在全球范围内15个中心应用于疾病的人体研究。为了发展临床应用，需要进行多中心研究最佳实践的共识。本文介绍了由具有HP [1-13C]丙酮酸盐人体研究经验的专家进行的两轮正式共识建设活动的结果。来自13个站点的29名参与者汇聚了药物方法、MR物理学、翻译成像和数据分析方面的专业知识，旨在就HP [1-13C]丙酮酸盐MRI多中心人体研究提供建议和最佳实践声明。总体而言，该小组对问卷中的大约三分之二的246个陈述达成了共识，这些陈述涵盖了“HP 13C丙酮酸盐制备”、“MRI系统安装、校准和幻影”、“采集和重建”以及“数据分析和量化”。各类别中的共识包括：（i）人类研究中可以使用不同的HP丙酮酸盐制备方法，但必须遵循相同的释放标准；（ii）必须使用幻影进行站点认证和质量保证，且必须使用相同的磁场强度，而系统的其余设置和校准方法可由各个站点决定；（iii）使用相同的脉冲序列和重建方法是可取的，但确切的选择应由解剖目标来决定；（iv）正常化的代谢产物曲线下面积（AUC值）和代谢产物AUC是首选的代谢指标。这项工作确认了多中心研究实践的共识领域，并确定了需要进一步研究以确定最佳实践的地方。

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Summary：
极化[¹³C]丙酮酸磁共振成像允许体内代谢评估，并已翻译成全球15个研究中心的疾病研究。本文介绍了通过具有人体极化[¹³C]丙酮酸研究经验的专家进行的两轮正式共识建设活动的结果，目的是提供关于多中心人体极化[¹³C]丙酮酸磁共振成像研究的建议及最佳实践声明。专家就问卷中的大约三分之二的陈述达成共识，涵盖了多个方面的共识，包括最佳实践建议需要进一步研究的领域。

Key Takeaways：