Surgery remains the primary treatment option for early-stage breast cancer, yet 1 in 4 patients will require re-operation after surgery. The consequences include delayed adjuvant treatment, increased likelihood of distant recurrence, poorer cosmetic outcomes, increased risk of infection, emotional distress, and enormous financial cost to the NHS. Each re-operation costs c£25k, leading to a staggering cost of £200mn and $1.5bn annually to the UK and US healthcare systems respectively. Breast cancer recurs so frequently after surgery because surgeons have no robust means to detect cancer during surgery other than visual and tactile assessment. Consequently, there is a tremendous medical need for improved tools to detect cancerous tissue during surgery. Lightpoint Medical is developing a molecular imaging fibrescope to detect cancer in real time during surgery, and thereby reduce the need for re-operation. The technology is based on Cerenkov Luminescence Imaging (CLI), a ground-breaking imaging modality that can perform optical imaging of Positron Emission Tomography (PET) imaging agents. Initial market research indicates a high demand for Lightpoint's technology among oncology surgeons. In our TSB proof-of-concept project, we successfully completed a bench-top demonstrator of the CLI fibrescope. In this project, we will collect surgeon-user feedback on the demonstrator, and develop a full prototype for further regulatory development and pivotal clinical trials. Additionally, we will development our reimbursement roadmap and economic model.

Nearly 1 in 4 breast cancer patients in the UK will see their cancer return after surgery. The consequences include repeat operations, delayed adjuvant treatment, increased likelihood of distant recurrence, poorer cosmetic outcomes, emotional distress, and enormous financial cost to the NHS. Breast cancer recurs after surgery primarily due to incomplete excision of the tumour or inadequate clearance of the surgical margins. Surgeons are unable to completely remove the cancerous tissue because the only tools they have to detect cancer during surgery are visual and tactile assessment. Consequently, there is a tremendous medical need for improved tools to detect cancer during surgery. Lightpoint Medical is developing a molecular imaging fiberscope to detect cancer in real time during surgery, and thereby tailoring the surgery to the individual patient's disease. The technology is based on Cerenkov Luminescence Imaging (CLI), a ground-breaking imaging modality that can perform optical imaging of Positron Emission Tomography (PET) imaging agents. Initial market research indicates a high demand for the technology among breast cancer surgeons in the UK and US. In this project Lightpoint and Guy’s Hospital will undertake a pilot clinical trial of the CLI fiberscope in breast-conserving surgery in order to assess the device's diagnostic performance. The results will be used to de-risk the technology before embarking on large-scale, pivotal clinical trials and to collect surgeon-user feedback on the device usability and performance.

Prostate cancer occurs in about one in seven of the male population and is fatal in about 20% of those cases, being the second most common cancer after lung cancer. Surgical intervention seeks to remove sufficient malignant tissue without leaving residuals that can lead to recurrence. At the same time new surgical techniques are emerging to minimise the impact on healthy tissue and preserve nerves and the quality of life. However, currently, the assessment of the success in removing all cancerous tissue depends on evaluation in a pathology lab and means that the surgery will not be curative or needs to be revisited. It is therefore crucial to develop technology that can allow the surgeon to make decisions during surgery that can reduce the chances of recurring disease. One well established indicator of cancerous tissue is the injection of a radioactively labelled tracer that differentiates between malignancy and normal tissue. This tracer can be imaged using positron emission tomography, but this is not a technology that can be utilized within a surgical setting. Recently a new methodology has been developed which allows the radioactive tracer to be imaged using ordinary cameras, by exploiting the emission by radioactive particles of Cerenkov light, in the visible spectrum. This phenomenon opens the possibility to place cameras on endoscopes and combine them with existing methods for robotic assisted surgery. In this project, we will pursue this idea, and make use of techniques for tracking movement of the cameras and the patient, including them in a model of light emission and detection, and realizing a real-time dynamic imaging system assisting the surgeon to excise all cancerous tissue while preserving as much healthy tissue as possible.

"There has been a 31% increase in the prevalence of head and neck cancer (HNC) in the UK over the past three decades, a trend which is set to accelerate over the next 20 years. Currently, 12,000 people are diagnosed with the disease each year and HNC is responsible for 4,000 deaths annually. By 2035, the incidence rate is predicted to soar by 33% with a 38% increase anticipated in mortality rates. Surgery is one of the primary treatments for HNC. The complete surgical removal of the cancer, indicated by a clear margin of healthy tissue around the excised tumour, is closely associated with an improved prognosis for patients. However, surgeons are very limited in their ability to ensure that a clear margin is achieved. Reliant on the crude methods of visual inspection and palpation to identify the full extent of the tumour, surgeons frequently leave cancer behind. As a result, patients require additional treatments, including repeat operations, radiotherapy and chemotherapy, which can severely impact quality of life and add a substantial financial burden to the NHS. Therefore, the accurate identification and removal of cancer during surgery is critical to improve patient outcomes and health system efficiencies. Intra-operative frozen section analysis (FSA) has been used for decades in the NHS to help oncology surgeons try to achieve clear margins, yet its performance limitations are widely acknowledged. It is also time-consuming and labour intensive, adding substantial cost to the NHS. The proposed study will compare the performance and cost effectiveness of a novel intra-operative imaging device, the LightPath Imaging System, against gold-standard histopathology and FSA to assess whether LightPath could offer HNC patients better outcomes at a lower cost to the NHS. Proven in breast and prostate cancer surgery, the LightPath Imaging System is a CE-marked diagnostic device. The proposed study, which will be the first use of LightPath in HNC surgery, will be run at the world-renowned cancer centre, The Royal Marsden Hospital in London, by the eminent HNC surgeon, Professor Vinidh Paleri. The device promises the potential to significantly improve HNC patient outcomes at the same time as substantially reducing NHS costs. The study will therefore aim to provide initial data to substantiate performance and health economic claims in HNC surgery to aid the rapid translation of the technology into the NHS."

Medical imaging has transformed clinical medicine in the last 40 years. Diagnostic imaging provides the means to probe the structure and function of the human body without having to cut open the body to see disease or injury. Imaging is sensitive to changes associated with the early stages of cancer allowing detection of disease at a sufficient early stage to have a major impact on long-term survival. Combining imaging with therapy delivery and surgery enables 3D imaging to be used for guidance, i.e. minimising harm to surrounding tissue and increasing the likelihood of a successful outcome. The UK has consistently been at the forefront of many of these developments. Despite these advances we still do not know the most basic mechanisms and aetiology of many of the most disabling and dangerous diseases. Cancer survival remains stubbornly low for many of the most common cancers such as lung, head and neck, liver, pancreas. Some of the most distressing neurological disorders such as the dementias, multiple sclerosis, epilepsy and some of the more common brain cancers, still have woefully poor long term cure rates. Imaging is the primary means of diagnosis and for studying disease progression and response to treatment. To fully achieve its potential imaging needs to be coupled with computational modelling of biological function and its relationship to tissue structure at multiple scales. The advent of powerful computing has opened up exciting opportunities to better understand disease initiation and progression and to guide and assess the effectiveness of therapies. Meanwhile novel imaging methods, such as photoacoustics, and combinations of technologies such as simultaneous PET and MRI, have created entirely new ways of looking at healthy function and disturbances to normal function associated with early and late disease progression. It is becoming increasingly clear that a multi-parameter, multi-scale and multi-sensor approach combining advanced sensor design with advanced computational methods in image formation and biological systems modelling is the way forward. The EPSRC Centre for Doctoral Training in Medical Imaging will provide comprehensive and integrative doctoral training in imaging sciences and methods. The programme has a strong focus on new image acquisition technologies, novel data analysis methods and integration with computational modelling. This will be a 4-year PhD programme designed to prepare students for successful careers in academia, industry and the healthcare sector. It comprises an MRes year in which the student will gain core competencies in this rapidly developing field, plus the skills to innovate both with imaging devices and with computational methods. During the PhD (years 2 to 4) the student will undertake an in-depth study of an aspect of medical imaging and its application to healthcare and will seek innovative solutions to challenging problems. Most projects will be strongly multi-disciplinary with a principle supervisor being a computer scientist, physicist, mathematician or engineer, a second supervisor from a clinical or life science background, and an industrial supervisor when required. Each project will lie in the EPSRC's remit. The Centre will comprise 72 students at its peak after 4 years and will be obtaining dedicated space and facilities. The participating departments are strongly supportive of this initiative and will encourage new academic appointees to actively participate in its delivery. The Centre will fill a significant skills gap that has been identified and our graduates will have a major impact in academic research in his area, industrial developments including attracting inward investment and driving forward start-ups, and in advocacy of this important and expanding area of medical engineering.