New technology to improve capability for clinical radiopharmaceutical production

提高临床放射性药物生产能力的新技术

• 批准号: MR/S005501/1
• 负责人: Steve Archibald
• 金额: $ 71.28万
• 依托单位: University of Hull
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2019
• 资助国家: 英国
• 起止时间: 2019 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FS005501%2F1
• 关键词: New; technology; improve; capability; clinical

This research will produce an operational prototype to make medical imaging drugs at, or near to, a hospital. Molecular imaging techniques (where a molecule is tagged with radioactive atom, injected into the patient and then tracked inside the body using a scanner) are increasingly becoming a key part of the clinical diagnostic pathway. They can detect a disease at an early stage and offer more precise information on how it will progress, also indicating the best possible treatment option in many cases.The aim of this research is to develop devices improve the access to molecular imaging technologies that offer better diagnosis of disease.These medical imaging techniques (particularly position emission tomography or PET) rely on radioactive atoms that are short lived (i.e. they decay away rapidly over hours or even minutes). This requires a small scale "drug factory", which in many cases must be on the same site as the patient due to the "feedstock material" decaying over time. Efficient conversion into the drug form is needed, it will be checked for purity and rapidly passed on for patient imaging. These molecular imaging techniques are mainly applied to cancers but there are new applications for the diagnosis of cardiac disease and also dementia. This research work will focus on a particular molecular imaging agent to improve detection and understanding of prostate cancer, which is likely to be required at many hospital sites around the UK. The NHS is already developing a strategy for how it will be included in patient assessment pathways but will need to invest in infrastructure to achieve this. Reducing the cost (both of the production device itself and the required infrastructure) will increase the availability to patients.The method we are using to deliver this, is to apply some of the latest advances in microfluidic technology developed by the University of Hull research team. This technology which deals with miniaturised devices handling low volumes to allow chemical synthesis of imaging drug molecules on a small scale with high efficiency. The Hull team are world leaders in this area. They have reported their initial results on at international nuclear medicines conferences and in scientific papers, and have also applied for five patents on this technology.The key deliverables are the production and validation of an operational prototype device that can be taken into a clinical radiopharmacy and allow us to work along the clinical staff to show how this technology can be used to improve availability of diagnostic agents, particularly in cancer. All of these technologies are regulated to ensure their safe operation and we will engage and work with the regulators to ensure that the new technology can be safely used in the clinical setting (where clean rooms and standard operating procedures must be followed to ensure patient safety).The project will be carried out between the University of Hull and the Hull and East Yorkshire NHS with the use of facilities on both the University of Hull site and the Castle Hill Hospital NHS site. It also involves King's College London as a project partner. We will work with collaborators in Uruguay and the USA, testing the imaging drug production unit in their clinical facilities to see how it fits in with their production procedures and regulations, which differ from those in the UK. We will also collaborate with Alliance Medical Ltd., the biggest supplier of positron emission tomography scanning services in the world and primary provider to the NHS, as part of the project.The new technology will allow the production of the tracers in a more streamlined manner that will give clinicians access to a greater number of tools to assess and diagnose their patients. More effective tools will give improved outcomes and the technology will offer cost effective access to these technologies for the NHS and other healthcare organisations worldwide.

这项研究将产生一个可操作的原型，使医疗成像药物在医院或附近。分子成像技术（将放射性原子标记在分子上，注射到患者体内，然后使用扫描仪在体内进行跟踪）正日益成为临床诊断途径的关键部分。它们可以在早期发现疾病，并提供有关疾病进展的更准确信息，也表明在许多情况下最好的治疗选择。这项研究的目的是开发设备，改善获得分子成像技术，提供更好的疾病诊断。这些医学成像技术（特别是正电子发射断层扫描或PET）依赖于寿命短的放射性原子（即，它们在数小时甚至数分钟内迅速衰减）。这需要一个小规模的“制药厂”，在许多情况下，由于“原料”随着时间的推移而腐烂，因此必须与患者在同一地点。需要有效地转化为药物形式，它将被检查纯度并迅速传递给患者成像。这些分子成像技术主要应用于癌症，但在心脏病和痴呆症的诊断方面也有新的应用。这项研究工作将集中在一个特定的分子成像剂，以提高检测和了解前列腺癌，这是可能需要在英国各地的许多医院网站。NHS已经在制定如何将其纳入患者评估途径的战略，但需要投资基础设施来实现这一目标。降低成本（生产设备本身和所需的基础设施）将增加患者的可用性。我们正在使用的方法来提供这一点，是应用船体大学研究团队开发的微流体技术的一些最新进展。该技术涉及处理小体积的小型设备，以允许小规模高效地化学合成成像药物分子。船体团队是这一领域的世界领导者。他们已在国际核医学会议和科学论文中报告了初步成果，并申请了该技术的五项专利。主要可交付成果是生产和验证可用于临床放射性药物的操作原型装置，并使我们能够沿着临床工作人员展示如何使用该技术来提高诊断剂的可用性，特别是在癌症中。所有这些技术都受到监管，以确保其安全运行，我们将与监管机构合作，以确保新技术可以安全地用于临床环境。（必须遵守洁净室和标准操作程序，以确保患者安全）。该项目将在船体大学和船体以及东约克郡国民保健服务机构之间进行，船体网站和城堡山医院NHS网站。该项目还邀请伦敦国王学院作为项目合作伙伴。我们将与乌拉圭和美国的合作者合作，在他们的临床设施中测试成像药物生产单元，以了解它如何符合他们的生产程序和法规，这些程序和法规与英国不同。我们还将与联盟医疗有限公司合作，作为该项目的一部分，世界上最大的正电子发射断层扫描服务供应商和NHS的主要供应商。新技术将允许以更简化的方式生产示踪剂，这将使临床医生获得更多的工具来评估和诊断他们的病人。更有效的工具将提供更好的结果，该技术将为NHS和全球其他医疗保健组织提供具有成本效益的技术。

项目成果

MONOLITHS AS MICROREACTORS FOR 68GA PROCESSING AND RADIOLABELING

巨石作为 68GA 处理和放射性标记的微反应器

• 发表时间: 2021
• 期刊: MicroTAS 2021 - 25th International Conference on Miniaturized Systems for Chemistry and Life Sciences
• 作者: He P.

Developing the future of clinical radiopharmacy: Optimising on-chip gallium-68 radiolabelling for pet imaging

开发临床放射性药物的未来：优化用于宠物成像的片上镓 68 放射性标记

• 发表时间: 2020
• 期刊: MicroTAS 2020 - 24th International Conference on Miniaturized Systems for Chemistry and Life Sciences
• 作者: Nail V.