Oxygen enhanced lung MRI - towards clinical application

“非电离或低剂量成像技术对肺部的服务很差。胸部CT扫描是可用的主要技术，但由于不可接受的高辐射剂量，特别是在儿童中，不允许常规随访或纵向监测。Bioxydyn有限公司是一家成像服务公司，为制药、临床和学术客户提供定量MRI生物标志物，于2010年从曼彻斯特大学分拆出来，拥有专有技术，可提供肺部MRI，称为氧增强MRI （OE-MRI）。自2012年以来，它一直基于这种能力向制药公司提供服务，因为已知它可以在患者数量较少的情况下显示疾病和药物效果。虽然Bioxydyn已经为制药临床试验提供了OE-MRI，但其长期目标是进一步开发和验证成像服务客户的技术，并推动其在呼吸系统疾病临床管理中的应用。Bioxydyn及其临床合作伙伴认为，OE-MRI能够比目前的临床判断更早地预测呼吸治疗的有效性。电子磁共振成像作为一种治疗选择工具具有商业效益，特别是对于昂贵的生物制剂，例如严重哮喘。OE-MRI在改善儿童囊性纤维化的治疗方面也有重要的机会。最终，对于商业应用，这需要在临床环境中得到证明。迄今为止，Bioxydyn已经优化了图像采集协议，将其安装在常规临床扫描仪上，在可靠的软件中实现了信号处理技术，并开发了质量控制技术。最重要的是，来自关键意见领袖的试点数据显示了OE-MRI在表征疾病和显示治疗反应方面的潜力（例如Martini et. al. 2018）。这些措施是通过2014年的InnovateUK项目和随后的内部努力实现的。这项申请现在涉及到在主要的多中心研究之前所需的开发的最后一部分，这些研究旨在证明临床和经济效益。通过这个项目，Bioxydyn及其临床主要合作伙伴将拥有建立主要多中心临床试验所需的所有工具和数据，旨在证明NHS和制药公司的临床和商业效益。”

"The lung is poorly served by non-ionising or low-dose imaging technologies. Thoracic CT scanning is the main technique available, but does not permit routine follow-up or longitudinal monitoring because of the unacceptably high radiation dose, especially in children.Bioxydyn Ltd is an imaging services business offering quantitative MRI biomarkers for pharma, clinical and academic clients and was spun out of the University of Manchester in 2010 with proprietary technology offering MRI in the lung known as oxygen-enhanced MRI (OE-MRI). It has provided services based on this capability to pharma since 2012, as it is known to show disease and drug effects with low patient numbers. While Bioxydyn has delivered OE-MRI for pharma clinical trials, long term ambitions are to further develop and validate the technique for imaging services customers and to drive its adoption in clinical management of respiratory diseases.Bioxydyn and its clinical partners believe that OE-MRI is capable of predicting the effectiveness of respiratory therapies much earlier than the current clinical judgements. OE-MRI has commercial benefit as a therapy selection tool, especially for expensive biologics in, for example, severe asthma. OE-MRI also has a significant opportunity to improve the management of cystic fibrosis in children. Ultimately, for commercial adoption, this needs to be proven in a clinical setting.Bioxydyn has so far optimised the image acquisition protocol, installed it on routine clinical scanners, implemented signal processing techniques in reliable software and developed quality control techniques. Most importantly, pilot data from key opinion leaders show the potential of OE-MRI to characterise disease and show therapy response (e.g. Martini et. al. 2018). These steps were achieved through a 2014 InnovateUK project and subsequent in-house efforts.This application now concerns the final pieces of development required before major multicenter studies designed to prove clinical and economic benefit.With this project Bioxydyn and its clinical lead partners will have all of the tools and data necessary to establish major multi-centre clinical trials designed to prove clinical and commercial benefit to the NHS and pharma."