New technology to improve capability for clinical radiopharmaceutical production

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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.