Implantable Microsystems for Personalised Anti-Cancer Therapy

Cancer is a well-known and much-feared killer disease, accounting for over a million deaths each year in Europe alone. Currently, radiotherapy and chemotherapy are the primary forms of treatment. They are delivered on a regular (often weekly) schedule based on the experience of clinicians and the availability of equipment and staff for treatment, to locations that are determined by the results of CT or MRI scanning. Chemotherapy is generally administered systemically, either as an injection or orally and thus affects regions of the body that have nothing to do with the tumour.
IMPACT(*) will develop tiny silicon chips to be placed inside the patient's body, close to a tumour to measure the cancer's "activity" very precisely in both space and time. The chips will measure simple quantities such as acidity, temperature and oxygen concentration and also more complex and difficult quantities such as the levels of particular proteins that indicate the status of the tumour and the death of cancer cells within it. They will concentrate on measuring the tumour's current vulnerability to radio- and chemo-therapy, and thus where and when that therapy should be targeted. With this knowledge, radiotherapy can be delivered to the right place and the right time to do maximum damage to a tumour. Similarly, by further developing a miniaturised, on-chip drug-delivery capability to protect its sensors from "biofouling", IMPACT paves the way for systems that can also administer chemotherapy to the right place and at the right time.
The work in IMPACT is therefore designed to meet a clinical priority that has been stressed by cancer specialists. The scientific and technical challenges are, however to Chemists and (silicon) Engineers. Sensors must be developed, many of them entirely novel, which make the correct measurements. These sensors must then be placed on silicon, with all the support circuits, wireless communications and safety features that this implanted medical diagnostic and therapeutic system needs.
IMPACT is therefore led by a team of engineers, chemists and both medical and veterinary clinicians. It also includes social scientists, as its results have the potential to revolutionise the way in which cancers are treated. IMPACT's implication is that the timing and location of treatment will be highly patient-specific. Careful consideration of the ethics, risks and regulation of such technology is vital from its inception as IMPACT's success will challenge both patients' perceptions and the organisation and scheduling of therapy.

It will also save many lives.

(*) Implantable Microsystems for Personalised Anti-Cancer Therapy.

Clinical, translational research in radiotherapy is a current priority of the UK Cancer Research Institute and IMPACT's beneficiaries are cancer patients, doctors and drug companies, in the context of many common malignancies. Radiotherapy is currently delivered in small equal daily doses over several weeks, according to a schedule based on availability of service. IMPACT will allow both dose and timing to be personalised to the biology of a patient's tumour, reducing cancer mortality and NHS costs dramatically. If proof of principle is shown in animals, IMPACT will ultimately lead to randomised clinical trials in which patients would be invited to participate to establish high level evidence of clinical and cost effectiveness compared to standard care.
Clinicians and oncologists of both human and animal patients are CIs on this project. To maximise the speed with which IMPACT's results can move through clinical trials and into real usage, IMPACT will develop focus groups to explore patients' views and concerns about implantable devices to prepare for clinical testing. We will also consult existing patient advocacy groups on these issues. Cancer treatment is an emotive subject that is of enormous public interest. It is vital that a project with IMPACT's aims communicate its work to the public and to decision-makers, without creating expectations of an imminent miracle cure. We have therefore asked for specific funding for training in public communications to prepare the researchers employed on IMPACT to undertake both casual public engagement on their work and also to be available for wider media engagement (e.g. at Science Festivals). To ensure effective and efficient impact, we will; (i) hold an open workshop in years 2 and 4 of IMPACT (ii) access creativity@home to facilitate lateral thinking within the project team and with workshop participants with respect to IMPACT's research and its wider impact (iii) disseminate the acquired multi-disciplinary skill and knowledge of the team via science festivals, laboratory visits (iv) produce a series of short, web-mounted video clips to be produced in which researchers explain their work in an accessible manner to promote collaboration and public understanding.

The commercial impact of a new technology that is (a) mass-produced and (b) widely applicable to a range of cancers will be significant. Implantable sensor chips can be manufactured as a generic underlying silicon platform technology with different sensors and possibly form factors for different cancers. Additional potential commercial developments include stereotactic devices to implant the biosensors, novel biomarkers, imaging technologies to verify their position and radiotherapy planning software and linear accelerators adapted to exploit patient-specific biological data. Throughout the project, we will consider patent protection for individual elements (eg sensors) and for the platform technology with a view to either licensing to a major biomedical vendor or company spinout. In anticipation of such commercial development and to fully explore commercial potential we will require translation funding. Working in partnership with the University of Edinburgh's research & commercialisation/technology transfer office, who seek to promote research and commercialisation activities to potential research sponsors and collaborators, licensees or investors, an exploitation plan will be put in place, that will be regularly reviewed and updated during the course of the project and commercial development opportunities explored in the later part of the project. Existing relationships with Cancer Research UK (in Edinburgh) provide a direct conduit to wider medical collaboration and also to exploitation through organisation and companies involved the production of cancer-treatment equipment and drugs.