New technology to improve capability for clinical radiopharmaceutical production

这项研究将产生一个可操作的原型，用于在医院或医院附近制造医学成像药物。分子成像技术（用放射性原子标记分子，注射到病人体内，然后用扫描仪在体内追踪）正日益成为临床诊断途径的关键部分。它们可以在早期阶段发现疾病，并提供有关疾病发展的更精确信息，在许多情况下还可以指出可能的最佳治疗方案。这项研究的目的是开发设备，提高分子成像技术的可及性，从而更好地诊断疾病。这些医学成像技术（特别是位置发射断层扫描或PET）依赖于寿命短的放射性原子（即它们在几小时甚至几分钟内迅速衰变）。这需要一个小规模的“药物工厂”，在许多情况下，由于“原料”随着时间的推移而腐烂，它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种特殊的分子显像剂上，以提高对前列腺癌的检测和理解，这可能是英国许多医院所需要的。NHS已经制定了一项战略，将如何将其纳入患者评估途径，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基础设施的成本）将增加对患者的可用性。我们使用的方法是应用赫尔大学研究团队开发的微流体技术的一些最新进展。该技术处理小体积的小型化设备，使成像药物分子的化学合成在小范围内具有高效率。赫尔队在这方面是世界领先的。他们已经在国际核医学会议和科学论文中报告了他们的初步成果，并且还为这项技术申请了五项专利。关键成果是生产和验证可用于临床放射药理学的可操作原型设备，并使我们能够与临床工作人员一起展示如何使用这项技术来提高诊断试剂的可用性，特别是在癌症方面。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，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）。该项目将在赫尔大学、赫尔和东约克郡NHS之间进行，同时使用赫尔大学和城堡山医院NHS的设施。它还包括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，看看它如何符合他们的生产程序和法规，这与英国的不同。作为项目的一部分，我们还将与联盟医疗有限公司合作，该公司是世界上最大的正电子发射断层扫描服务供应商，也是NHS的主要供应商。这项新技术将使示踪剂的生产更加简化，从而使临床医生能够使用更多的工具来评估和诊断患者。更有效的工具将带来更好的结果，该技术将为NHS和全球其他医疗机构提供成本效益更高的技术。

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.