Gadopiclenol

拜耳新型在研MR对比剂Gadoquatrane，以及其已获批的MR对比剂钆布醇的最新研究和临床开发数据，将于2024年欧洲放射学大会（ECR）上呈现与放射学AI技术提供商Keya Medical Inc.和Circle Cardiovascular Imaging Inc.建立了新的合作伙伴关系，并推出了拜耳医学影像平台Calantic™ Digital Solutions新的心脏服务线（Cardiac Service Line），并启动针对临床实践中人工智能应用的综合教育计划推出面向外部客户的医学影像核心实验室服务（Medical Imaging Core Lab Services）拜耳在其全面的影像诊断领域产品组合以及数字业务和服务的扩展方面不断取得进展。公司近日宣布，将在2024年2月28日至3月3日在奥地利维也纳举行的欧洲放射学大会（ECR）上，展示Gadoquatrane的最新临床和前临床数据。Gadoquatrane是拜耳目前处于III期临床开发的新型大环状钆对比剂。同时，拜耳还宣布了与放射学AI技术提供商Keya Medical Inc.和Circle Cardiovascular Imaging Inc.的新协议，旨在扩张其医学影像平台Calantic™ 数字解决方案的产品管线和服务范围，并在大会上上即将推出新的医学成像核心实验室服务（Medical Imaging Core Lab Services）。拜耳在欧洲放射学大会（ECR）的系列活动彰显了其作为放射学核心领域领导者的坚定承诺，致力于应对行业当前面临的挑战并推动医疗创新，以更好地服务医疗提供者及患者，这其中也包括发挥人工智能巨大的应用潜能。Gadoquatrane和钆布醇相关新进展拜耳目前处于III期临床开发的新型在研大环状钆对比剂（GBCA）Gadoquatrane，有望显著降低临床上接受增强MRI扫描患者所需的临床钆（Gd）剂量。今年的ECR上，拜耳将展示已发表的Gadoquatrane新的临床前和临床数据，以及基于文献的对拜耳现有大环状钆对比剂（GBCA）钆布醇的安全性和有效性的综述分析：向上滑动阅览钆基对比剂重复给药后大鼠皮肤中残留钆的化学形态的定量与评估该项研究利用基质辅助激光解吸/离子化质谱成像技术，探讨了钆对比剂钆布醇 （GBCAs）在皮肤中的分布及其化学形态。结果显示，残留钆的化学形态为完整的钆螯合物，未观察到游离钆脱螯合迹象。钆布醇在皮肤中的水平较低，五周内达到检测水平。骨骼中钆含量的评估：对比新型高弛豫率含钆对比剂Gadoquatrane和Gadopiclenol的研究该项研究聚焦于Gadoquatrane和Gadopiclenol这两种新型大环GBCA给药后大鼠股骨中的钆含量、剂量依赖性和分布。使用已批准的大环钆对比剂钆布醇作为参考标准。对大鼠注射等同剂量的钆一周后，相较于钆布醇，注射Gadoquatrane的大鼠股骨中钆浓度降低了50%。Gadopiclenol给药后股骨中钆水平最高，比Gadoquatrane高出5倍，比钆布醇高出1.9倍。 新型高弛豫率大环型钆对比剂Gadoquatrane和Gadopiclenol的理化性质比较该研究首次评估了对比剂Gadoquatrane和Gadopiclenol的理化性质，包括r1-弛豫率和螯合物稳定性。研究比较了新型MRI对比剂Gadopiclenol和Gadoquatrane的物理化学性质，受人体血浆差异的影响，发现两种对比剂的r1弛豫率均为Gadobutrol的两倍以上。Gadoquatrane在血浆中的钆释放量低于定量下限，而Gadopiclenol在15天内仍表现出可检测的钆释放量。在低pH值下，Gadoquatrane较Gadopiclenol显示出更慢的Gd3+（钆离子）释放速率，进一步突显了Gadoquatrane的稳定性。基于临床试验数据、建模与模拟方法及体外数据评估Gadoquatrane在肾损伤患者种的药代动力学和安全性以及其透析性该项研究聚焦于Gadoquatrane在肾损伤患者中的药代动力学和安全性，采用临床试验数据结合建模和模拟方法，以及体外测试来评估透析能力。该研究借鉴了广泛的含钆对比剂（GBCAs）类药物知识，避免了在临床试验中的易感群体即严重肾功能损伤患者的对比剂暴露。钆布醇：超过25年的应用、超过一亿次给药的经验回顾在过去的25年，全球钆布醇给药次数已超过1亿次。两篇基于文献的综述论文将在ECR作为Electronic Poster Sessions （EPOS）呈报，其目的是对钆布醇在9个已批准适应症和儿童中使用的临床安全性以及有效性进行深入回顾和最新状态分析。研究再次证实，大量临床研究在广泛适应症范围内记录了钆布醇的长期应用经验，并确立了其在所有批准适应症和人群中的良好风险-效益比。用于评估的证据主要集中在疗效方面，涵盖了65项研究，共7,806名患者，其中包括271名儿童，研究结果表明钆布醇作为MR对比剂，在全身已批准适应症、全年龄段均显示出高效能。通过AI创新推动放射学进步在拜耳展位，参观者可以通过沉浸式体验了解拜耳不断发展的放射学未来——拜耳体验中心。在AI Theatre，专家们齐聚一堂，讨论关于人工智能在放射学中的角色以及其在临床实践中实施的热点问题——如数据隐私和伦理、行业标准和监测、以及AI教育的关键作用。在一个联合圆桌会议上，拜耳及其合作伙伴Google Cloud的专家将讨论放射学云技术的相关洞察。关于Calantic™ Digital Solutions平台概述值此2024 ECR之际，拜耳还宣布了扩展其医学影像平台Calantic™ 数字化解决方案：放射学AI技术提供商Keya Medical和Circle Cardiovascular Imaging将在该平台上构建新的心脏服务管线（Cardiac Service Line）。该临床服务管线绑定了最新AI算法，有助于针对心血管相关疾病的辅助诊断。推出拜耳的Medical Imaging Core Lab Services此外，拜耳首次在ECR展示了其医学影像核心实验室服务（Medical Imaging Core Lab Services）。目前，整个行业正在进行的临床试验的一半，以及90%的肿瘤学试验，都将医学影像作为评估研究药物的安全性和有效性的必要手段，并支持研究的整体结论。在过去十年中，利用医学影像的临床试验数量增加了500%。除了提供给临床试验的医学影像服务外，这一综合服务还提供端对端影像核心实验室解决方案、科学咨询、基于云的图像采集、质量控制、评估和管理、以及实时操作和质量指标。其服务网络包含了40多名核心专家、100多名内部和外部相关医师和放射科医生。目前参与了拜耳及其平台公司的50多项临床试验，以及软件作为医疗器械（SaMD）的内部开发。随着2024年ECR的正式发布，拜耳的影像核心实验室服务将向外部客户开放。* 上文中提到的产品（Calantic™ Digital Solutions）目前尚未在中国上市向上滑动阅览关于拜耳的Gadoquatrane临床开发项目拜耳，作为全球放射学领域的领导企业，于2023年6月启动了III期临床开发项目QUANTI，其目的是评估下一代细胞外大环含钆对比剂（GBCA）Gadoquatrane用于磁共振成像（MRI）的有效性和安全性。Gadoquatrane是一种高稳定性MRI对比剂，具有高弛豫率，有可能大幅降低接受对比增强MRI患者的钆（Gd）剂量。QUANTI临床开发方案包括两项多中心III期研究，即QUANTI CNS （中枢神经系统）和QUANTI OBR （其他身体部位）以及一项儿科研究，所有试验性Gadoquatrane的剂量均为0.04 mmol Gd/kg体重（BW）。这代表着与已批准的大环GBCA标准剂量（0.1 mmol Gd/kg BW）相比，对比增强MRI中钆剂量下降了60%，如果试验成功，这将是多用途MRI对比剂的最低钆剂量。对比增强MRI在医疗保健体系中起着重要作用，它提供了一种无辐射、非侵入性方法来采集详细的身体影像、帮助区分和识别器官和组织中的潜在异常并支持医师回答疾病检测、表征和监测中的重要医学问题。关于AI在放射学中的应用2022年全球医学影像AI领域销售额超过5亿美元，预计将持续强劲增长。预计年复合增长率为25%，至2027年市场规模将达到17亿美元。随着人口老龄化和生活方式的改变，心血管疾病和癌症等慢病数量不断增加，对人工智能驱动的创新需求超过以往，对能够诊断疾病、指导治疗决策和支持治疗计划的医学影像的需求正在不断增长。人工智能可以加速诊断流程，提升放射检查业务量和服务质量。时间压力和庞大工作量通常让很多放射科医生疲惫不堪，也让医学影像人工智能技术显得更加重要。更加令人担忧的是，训练有素的放射科医生数量严重不足。此外，诊断失误随着加班时间的延长而上升：2018年发表的一篇论文称，全球每年有约4000万个与影像相关的诊断错误产生。而人工智能技术可以有效帮助管理放射科医生及团队不断增加的工作量，最终改善患者关护。关于Calantic™ Digital SolutionsCalantic数字化解决方案是一套支持数字化影像诊断的人工智能应用程序，旨在协助放射科医生及团队在患者治疗过程中的关键步骤提供支持。Calantic为AI厂商提供中立、基于云的综合解决方案平台，旨在支持疾病分诊、病灶检出、量化分析和诊断效率的转型提升。同时，自动化执行常规阅片任务和量化分析将有效改善放射科室的工作流程，并大大节省放射科医生及团队时间。该解决方案平台的设计基于身体部位编排，将包括针对胸部、神经、乳腺、前列腺、心脏和肝脏疾病的应用程序包。关于拜耳影像诊断业务作为一家在影像诊断领域有着百年历史传承的真正生命科学公司，拜耳致力于在从创新产品到优质服务的各个领域创造卓越，以支持高效且优化的患者照护。拜耳提供先进的产品组合，包括用于计算机断层扫描（CT）、X射线和磁共振成像（MRI）的对比剂、用于精准管理对比剂使用的设备、信息化解决方案，以及包括AI在内的各种应用程序的医学影像平台。拜耳大力投入研发，包括利用AI技术和推动医学成像领域创新。这些产品中的每一款都可以在诊断到护理的全过程提供对治疗很关键的答案和明确方向，帮助放射科医生开展工作。关于拜耳拜耳作为一家跨国企业，在生命科学领域的健康与农业方面具有核心竞争力。公司致力于通过产品和服务，帮助人们克服全球人口不断增长和老龄化带来的重大挑战，造福人类和地球繁荣发展。拜耳致力于推动可持续发展并对业务产生积极影响。同时，集团还通过科技创新和业务增长来提升盈利能力并创造价值。在全球，拜耳品牌代表着可信、可靠及优质。在2022财年，拜耳的员工人数约为101,000名，销售额为507亿欧元。不计特殊项目的研究开发投入为62亿欧元。更多信息请见www.bayer.com。前瞻性声明本新闻稿包括拜耳集团管理层基于当前设想和预测所作的前瞻性声明。各种已知和未知的风险、不确定性和其它因素均可能导致公司未来的实际运营结果、财务状况、发展或业绩与上述前瞻性表述中所作出的估计产生重大差异。这些因素包括在拜耳官方网站http://www.bayer.com/上公开的拜耳各项报告。本公司没有责任更新这些前瞻性声明或使其符合未来发生的事件或发展。

Following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and the recommendation sent by EMA to the European Committee (EC), the EC has granted Marketing Authorisation for Vueway® (gadopiclenol) in the European Union. Vueway® is a new, highly stable, macrocyclic gadolinium-based contrast agent (GBCA) for contrast-enhanced magnetic resonance imaging (CE-MRI): due to its high R1 relaxivity, in adequate and well controlled clinical studies it showed similar diagnostic efficacy when used at half the dose of gadobutrol, a GBCA routinely and widely used for CE-MRI1,2 Reduced dose compared with gadobutrol and other GBCAs implies reduced exposure of patients to gadolinium, and reduced release of the metal in the environment. Already approved in 2022 in the United States of America 3, where it is already used in clinical practice, Vueway® is now also approved in the European Union for use in CE-MRI of the central nervous system (CNS) and of several body organs, i.e., liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system in adult patients and paediatric patients aged 2 years and older. MILAN, Dec. 11, 2023 /PRNewswire/ -- Bracco Imaging S.p.A., an innovative world leader delivering end-to-end products and solutions through a comprehensive portfolio inclusive of precision diagnostic imaging modalities, announces that on December 7, 2023 the European Commission (EC) has granted the Marketing Authorisation for Vueway® (gadopiclenol) in the European Union (EU). The approval granted by the EC followed positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and the recommendation sent by EMA to the EC. Vueway® (gadopiclenol) is a solution for intravenous injection approved by the EC for use with contrast-enhanced magnetic resonance imaging (CE-MRI) in adult patients and children aged 2 years and older to improve detection and visualization of pathologies with disruption of the blood-brain-barrier (BBB) and/or abnormal vascularity of the brain, spine, and associated tissues of the central nervous system (CNS) and CE-MRI of several body organs, i.e., the liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system. In September 2022, gadopiclenol was approved by the Food and Drug Administration (FDA) for its use in MRI of the CNS and the Body in the United States of America (USA) 3, where the product is used in clinical practice at an increasing number of hospital systems. Vueway® (gadopiclenol) is a new highly stable, macrocyclic gadolinium-based contrast agent (GBCA) with the highest values of longitudinal (R1) relaxivity among all the GBCAs approved for use in the EU and the USA. 4 Thanks to its high relaxivity, large, multicenter, adequate and well controlled clinical studies have shown that Vueway® provides similar diagnostic efficacy at half the dose of gadobutrol, a GBCA routinely used in clinical practice in the EU. 1,2 "The final approval of gadopiclenol by the European Commission marks a significant milestone in the field of diagnostic imaging. Its availability empowers healthcare providers with a powerful tool that can aid in the detection and assessment of a wide range of diseases and conditions," said Christian Herold, Full Professor at the Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna, Vienna General Hospital Vienna, Austria. "From oncology to neurology, gastroenterology to musculoskeletal medicine, gadopiclenol has the potential to reshape the landscape of patient care across multiple specialties." The positive CHMP opinion, the EMA recommendation, and the final EC approval were based on the results from two prospective, large-scale, randomized, double-blind, crossover clinical studies, PICTURE and PROMISE, conducted in more than 500 adult patients undergoing contrast-enhanced MRI and aimed at comparing the safety and efficacy of 0.05 mmol/kg gadopiclenol compared with 0.1 mmol/kg gadobutrol1,2. The PICTURE trial demonstrated comparable diagnostic efficacy at half dose in MRI of the CNS 1, while the PROMISE trial demonstrated the same in MRI of the head and neck, chest, breast, liver, pancreas, pelvis organs, and the musculoskeletal system.2 A reduced dose compared with gadobutrol and other GBCAs implies reduced exposure of patients to gadolinium, and reduced release of the metal in the environment. "In our experience to date at MD Anderson with gadopiclenol, we have been pleased to be able to reduce our patients gadolinium exposure by half, while still achieving effective contrast enhancement. From today, European colleagues will be able to take advantage of this unique and highly potent solution," said Max Wintermark, Chairman of the Department of Neuroradiology, The University of Texas MD Anderson Cancer Center, Houston, Texas. "We are thrilled to announce this groundbreaking development, which marks a significant milestone in enhancing patient care. This innovation benefits healthcare providers but also, more importantly, patients who undergo MRI scans and those living with chronic conditions. Vueway will not only lower the rate of inaccurate or inconclusive results of MRI procedures but may also contribute to improve treatment plans tailored to individual patient needs," concluded Fulvio Renoldi Bracco, CEO Bracco Imaging SpA. About gadolinium-based contrast agents Gadolinium-based contrast agents (GBCAs) are widely and routinely used to enhance the diagnostic performance of magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) examinations.5 Gadolinium is a rare earth metal that has unique magnetic properties that make it useful for MRI imaging. About gadopiclenol Gadopiclenol, initially invented by Guerbet with subsequent contribution of Bracco intellectual property, is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity. The efficacy and safety of gadopiclenol have been evaluated in MRI of the central nervous system, head and neck, thorax, abdomen, pelvis, and musculoskeletal system (For US reference, refer to the FDA approved prescribing information). Details on Phase III clinical trials are available on : Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) Full Text View - ClinicalTrials.gov Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI) Full Text View - ClinicalTrials.gov About the PICTURE trial1 The PICTURE trial included 256 patients with known or highly suspected CNS lesion(s). All primary and secondary endpoints of the study were achieved. All blinded readers' evaluations indicated the superiority of the combined unenhanced/contrast-enhanced MRI with 0.05 mmol/kg gadopiclenol over unenhanced MRI alone for all lesion visualisation criteria (p<0.0001). For all three blinded readers, non-inferiority of 0.05 mmol/kg gadopiclenol to 0.1 mmol/kg gadobutrol (Gadavist) was demonstrated for all lesion visualisation criteria (p<0.0001). Results also indicated superior percent of contrast enhancement for all readers (p<0.0001), superior contrast-to-noise ratio for two out of three readers (p<0.01), and superior lesion-to-background contrast ratio with gadopiclenol for all readers (p<0.0001). In correlation with the greater contrast enhancement, the diagnostic quality of the images obtained with 0.05 mmol/kg gadopiclenol were in majority preferred over that provided by 0.1 mmol/kg gadobutrol by all three blinded readers (p<0.001). About the PROMISE trial2 The PROMISE trial included 273 adult patients suspected of having an enhancing abnormality in one of three different body regions (head/neck, breast/thorax/abdomen/pelvis, or musculoskeletal). Off-site blinded readers with expertise in the respective body regions rated border delineation, internal morphology, and visual contrast enhancement. All primary and secondary endpoints of the study were achieved. For all blinded readers, 0.05 mmol/kg gadopiclenol was non-inferior to 0.1 mmol/kg gadobutrol for all visualisation parameters and all readers (P<.001), and superior to unenhanced images (P<.001). Two of three readers yielded higher percentage enhancement for gadopiclenol (P<.001). Lesion-to-background ratio did not differ. For most participants (75%–83%), readers reported no preference between 0.05 mmol/kg gadopiclenol and 0.1 mmol/kg gadobutrol images. About Bracco Imaging Bracco Imaging S.p.A. ("Bracco Imaging"), part of the Bracco Group, is an innovative world leader delivering end-to-end products and solutions through its comprehensive portfolio across diagnostic imaging modalities. Headquartered in Milan, Italy, Bracco Imaging's purpose is to improve people's lives by shaping the future of prevention and precision diagnostic imaging. The Bracco Imaging portfolio includes products and solutions for all key diagnostic imaging modalities: X-ray imaging, magnetic resonance imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents. Bracco Imaging has approximately 3,700 employees and operates in more than 100 markets globally. Bracco Imaging has a well-skilled and innovative Research and Development (R&D) organization with an efficient process-oriented approach and track record in the diagnostic imaging industry. R&D activities are located in four centers based in Italy, Switzerland, the United Kingdom and the United States. Bracco Group global revenues were 1.7 billion Euros in 2020. To learn more about Bracco Imaging, visit . THE BRACCO IMAGING AND GUERBET COLLABORATION Bracco Imaging and Guerbet in December 2021 entered a worldwide collaboration on Gadopiclenol manufacturing and research and development activities. Gadopiclenol will be commercialized independently under separate brands. Both Guerbet and Bracco Imaging each own valuable intellectual property on Gadopiclenol. Furthermore, after an agreed transition period when Guerbet manufactures Gadopiclenol for both Guerbet and Bracco, both companies will manufacture the Gadopiclenol active ingredient and finished product. The strategic collaboration is expected to accelerate access to Gadopiclenol and deliver innovation, as well as better care to patients and caregivers alike. Bracco Imaging Micaela Colamasi PR Manager [email protected] +39 348 2314362 1 Loevner LA, Kolumban B, Hutóczki G, et al. Efficacy and Safety of Gadopiclenol for Contrast-Enhanced MRI of the Central Nervous System: The PICTURE Randomized Clinical Trial. Invest Radiol 2023; 58:307-313 2 Kuhl C, Csőszi T, Piskorski W, Miszalski T, Lee JM, Otto PM. Efficacy and Safety of Half-Dose Gadopiclenol versus Full-Dose Gadobutrol for Contrast-enhanced Body MRI. Radiology 2023; 308: e222612 3 Food and Drug Administration. Novel Drug Approvals in 2022. Available at: . Accessed December 8, 2023 4 Robic C, Port M, Rousseaux O, et al. Physicochemical and pharmacokinetic profiles of gadopiclenol: a new macrocyclic gadolinium chelate with high T1 relaxivity. Invest Radiol 2019; 54: 475-484 5 FDA. Information on Gadolinium-Based Contrast Agents. . Accessed December 8, 2023 SOURCE Bracco