Oxygen enhanced lung MRI - towards clinical application

“非电离或低剂量成像技术对肺部的作用很差。胸部CT扫描是可用的主要技术，但不允许常规随访或纵向监测，因为不可接受的高辐射剂量，特别是在儿童中。Bioxydyn Ltd是一家成像服务公司，为制药公司提供定量MRI生物标志物，临床和学术客户，并于2010年从曼彻斯特大学分拆出来，拥有专有技术，在肺部提供MRI，称为氧气-增强MRI（OE-MRI）。自2012年以来，它一直在为制药公司提供基于这种能力的服务，因为众所周知，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采用。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系统治疗的有效性。OE-MRI作为治疗选择工具具有商业效益，特别是对于例如严重哮喘中的昂贵生物制剂。OE-MRI也有很大的机会改善儿童囊性纤维化的管理。Bioxydyn迄今为止已经优化了图像采集协议，将其安装在常规临床扫描仪上，在可靠的软件中实施信号处理技术，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OE-MRI对诊断疾病的潜力并显示治疗反应（例如Martini et. 2018）。这些步骤是通过2014年的InnovateUK项目和随后的内部努力实现的。该申请现在涉及旨在证明临床和经济效益的主要多中心研究之前所需的最后开发部分。通过该项目，Bioxydyn及其临床主要合作伙伴将拥有建立主要多中心研究所需的所有工具和数据。中心的临床试验，旨在证明临床和商业利益的NHS和制药。"

"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."