Prostate cancer is the most common cancer among men with 12,000 men in the UK dying from the disease every year. 130 new cases of prostate cancer are diagnosed every day. Over the past 30 years, incidence of the disease has soared by over 40% with further increases predicted to 2035\. Surgery remains the primary treatment option for prostate cancer but is very often unsuccessful, largely due to the incomplete removal of cancerous tissue during an operation. In particular, cancerous cells around the primary tumour and lymph node metastases can be frequently missed during surgery. Surgeons often fail to remove all the cancer because there is no way to accurately detect cancer during surgery. They are completely dependent on their naked eye and sense of touch to identify all cancerous tissue. With the move towards minimally invasive, robotic surgery, surgeons are increasingly losing even their ability to use their sense of touch. Numerous technologies have attempted to address the pressing medical need to find cancer during surgery, but none have proven sufficiently accurate and cost-effective. Lightpoint Medical has developed an _in-vivo_ probe to detect prostate cancer intra-operatively. The device detects electron signals from an imaging agent administered to the patient prior to surgery which concentrates in cancerous cells. The electron signal has a small penetrative depth and therefore can accurately guide surgeons to any remaining cancerous tissues surrounding the tumour site, providing such precision to ensure the full removal of cancer and enable, where possible, the retention of healthy, functional tissue. The technology promises a complete transformation of outcomes for prostate cancer patients. Proof-of-concept for the probe has been achieved with a highly innovative and sophisticated data processing algorithm to ensure a clear signal from electron emissions to the exclusion of the background gamma signals. This project is a 12-month work programme to miniaturise the technology to a scale compatible with contemporary keyhole, robotic surgery. The outcome of the project will be a working prototype ready for pre-clinical validation.

Cancer is one of the leading public health challenges in the UK. Someone is diagnosed with the disease every two minutes. Cancer currently costs the UK £18.3B per annum in healthcare expenses and lost productivity. With predictions that by 2020 almost half of the population will be diagnosed with cancer within their lifetime, the health and economic implications for the UK are considerable. Surgery remains one of the primary treatment options for cancer patients, but is very often unsuccessful, largely due to the incomplete removal of cancerous tissue, or the cautious excision of healthy tissue. Surgery often fails because there is no way to accurately detect cancer in real-time during surgery. Surgeons are completely dependent on their naked eye and sense of touch to identify all of the cancerous tissue. With the move towards minimally-invasive, key-hole and robotic surgery, surgeons have now even lost their ability to use their sense of touch and their field of view is increasingly restricted. Numerous technologies have attempted to address the pressing medical need to detect cancer during surgery but none have proven sufficiently accurate and cost-effective. This project will rapidly advance the development of a miniaturised intra-operative cancer detection probe, EnLight, which is fully compatible with minimally invasive key-hole surgery and robotic surgical systems. The technology potentially offers rapid and high diagnostic performance for intra-operative cancer detection. Laboratory proof-of-concept for the probe has been achieved. This project will evaluate the clinical effectiveness of the technology for detecting cancer during prostate cancer surgery, which is the first priority cancer indication. At the conclusion, this project will deliver the necessary clinical data to establish safety and performance to help secure regulatory approval in the EU and US to initiate commercialisation and clinical translation.

"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."

Prostate cancer is the most common cancer among men with 12,000 men in the UK succumbing to the disease every year. Surgery remains the primary treatment option for prostate cancer but is very often unsuccessful, largely due to incomplete removal of cancerous tissue during an operation. In particular cancerous cells around the primary tumour and lymph node metastases can be frequently missed during surgery. Surgeons often fail to remove all of the cancer because there is no way to detect cancer during surgery. They are completely dependent on their naked eye and sense of touch to identify all of the cancerous tissue. With the move towards minimally-invasive surgery now surgeons have even lost their ability to use their sense of touch. Numerous technologies have attempted to address the pressing medical need to find cancer during the surgery but none have proven sufficiently accurate and cost-effective. Lightpoint Medical is developing a laparoscopic probe called EnLight to detect prostate cancer intraoperatively. The device detects gamma and electron signal from an imaging agent administered to the patient prior to surgery which concentrates in cancerous cells. The gamma signal is of sufficient depth to be able to guide surgeons to cancerous spread within the lymphatic system. The electron signal has a small penetrative depth and therefore can guide surgeons to any remaining cancerous tissues surrounding the primary tumour site. The technology potentially offers rapid and high diagnostic performance during surgery, promising a complete transformation of patient outcomes. Laboratory proof-of-concept for the laparoscopic probe has been achieved. This project is a short work programme to further optimise the electron detector to ensure full compatibility with clinical needs before proceeding to clinical testing. The aim of the project is to develop a data processing algorithm to increase the electron signal. The outcome of the project will be a pre-clinically validated device ready for first-in-man testing.

To embed user requirements into the development of novel imaging devices to enhance their translation into both a preclinical and clinical environment.

The project objective is to develop an entirely new detector technology for use in cancer surgery. Surgery remains the primary treatment option for many types of cancer. However, despite recent advances in medical imaging, surgeons surprisingly still rely on sight and touch to remove cancer, often leaving behind cancerous deposits. Cancers that require keyhole or laparoscopic surgery such as lung and colorectal cancer are even more challenging due to the restricted view of the surgical site. The project will therefore develop a technology capable of precisely locating cancer in real-time during keyhole surgery to help aid the detection and removal of cancerous tissue. The technology is based on a recent innovation in beta particle detection. Lightpoint Medical Ltd has secured the exclusive world-wide licence to develop and commercialise this innovation. The project will enable the company to develop the technology from concept to a basic working model that will be tested and validated in a laboratory. Successful commercialisation of the technology will generate important employment and growth opportunities for the wider UK economy. Critically, the project has the potential to have a transformative impact on patient outcomes.

Cancer frequently requires repeat operations. For example, nearly 1 in 4 patients in the UK undergoing surgery for early-stage breast cancer will require a re-operation. In some NHS trusts, the re-operation rate for breast cancer is as high as 70%. The consequences of reoperation are substantial including delayed drug treatment, increased likelihood of recurrence, higher risk of mastectomy and infection, poorer cosmetic outcomes, emotional distress for the patient, and enormous financial cost to the NHS. The cost of breast cancer re-operation in the UK is estimated at £200m per annum. Breast cancer surgery’s failure rate is so high because surgeons have no way to detect cancer during the operation. Today, surgeons still rely on their sense of touch to find remaining cancerous deposits during the operation. Consequently, there is an urgent medical need for improved tools to detect cancer in real-time during surgery and avoid re-operations. Lightpoint Medical is developing a ground-breaking imaging technology for imaging cancer in real-time during surgery. The technology is based on Cerenkov Luminescence Imaging (CLI), a new imaging modality that can perform optical imaging of Positron Emission Tomography (PET) imaging agents. The device called LightPath™ rapidly produces an image of any residual cancer, and informs the surgeon where to remove additional tissue. The technology has achieved proof-of-concept based on previous SMART funding from Innovate UK. In this project we will develop the technology to the stage of pre-production prototype.

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.

Forty thousand patients are diagnosed with prostate cancer in the UK every year, and eleven thousand succumb to the disease. Early detection followed by surgery remains the most effective strategy to combat prostate cancer, yet nearly 1 in 4 patients with localized prostate cancer will see their cancer recur after surgery. Prostate cancer recurs after surgery primarily due to incomplete excision of the cancer. Surgeons are unable to completely remove the cancerous tissue because the naked eye cannot detect small cancer deposits. Further, sparing the nerves responsible for erectile function and urinary continence is a high priority. Consequently, there is a tremendous medical need for more sensitive tools to detect cancer during surgery. Lightpoint Medical is developing a molecular imaging camera and laparoscope to detect cancer in real-time during surgery, and thereby reduce the chance of cancer recurring. 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. In this project we propose to conduct a pilot clinical trial for the CLI camera and laparoscope in prostate cancer surgery. The trial results will be used to assess the performance of the devices compared to gold-standard pathology, and to develop the next iteration of the products. Additionally, the UCL Centre for Medical Image Computing will research and develop an improved image processing module for the Lightpoint device.

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 means 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 camera to analyse surgical specimens in real time during surgery. 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. In this project we will undertake a pilot clinical trial of the CLI molecular imaging camera on breast cancer surgical specimens. The study will be conducted with our partners at Guy’s and St Thomas’ Hospital and King’s College, and will assess the camera's diagnostic performance compared to gold-standard pathology. The results will be used to plan the pivotal clinical trial, and design the next phase of the device.

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 require re-operation after surgery. The consequences, in addition to repeat operations, include delayed adjuvant treatment, increased likelihood of distant recurrence, poorer cosmetic outcomes, emotional distress, and enormous financial cost to the NHS. Breast cancer requires re-operation so frequently after surgery primarily due to incomplete excision of the tumour. Surgeons are unable to completely remove the cancerous tissue because the only tools surgeons 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. In this project, the consortium will explore the feasibility of a novel molecular imaging technology for analysing surgical specimens in real time during surgery. The technology is based on Cerenkov Luminescence Imaging (CLI), a groundbreaking imaging modality that can perform optical imaging of Positron Emission Tomography (PET) imaging agents. The consortium consists of an interdisciplinary team of engineer-entrepreneurs, medical device developers, biologists, and oncology surgeons. The project will evaluate the feasibility of the technology before embarking on full-scale prototype development and clinical testing.

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. 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 cancer 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 fibrescope to detect cancer in real-time during surgery, and thereby reduce the chance of cancer recurring. 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. The fibrescope is a flexible fibre optic bundle that the surgeon can use to image inside the surgical cavity. Initial market research supported by the TSB revealed a high demand for Lightpoint's technology among oncology surgeons. In this project, we will interview 15 breast cancer surgeons to collect their in-depth feedback on the fibrescope’s design, usability, performance, and workflow integration. The feedback from the surgeons will be used to improve the fibrescope design before embarking on fullscale product development and clinical trials.

Surgery is the primary treatment option for most types of cancer, yet cancer frequently recurs after surgery. In the UK, almost 1 in 4 breast cancer patients will require re-operation after surgery. The consequences include delayed adjuvant treatment, increased likelihood of distant recurrence, poorer cosmetic and functional outcomes, emotional distress, and financial cost. Cancer frequently requires re-operation due to incomplete excision of the tumor or inadequate clearance of surgical margins. Cancerous tissue fails to be completely excised because, during surgery, the surgeon can only rely on the visual appearance of the tumor and palpation to differentiate malignant versus benign tissue. Consequently, there is a tremendous need for improved tools to detect cancerous tissue during surgery. Lightpoint Medical is seeking to assess the technical and commercial feasibility of developing an intra-operative molecular imaging camera and endoscope to diagnose cancer in real-time during surgery. Image-guided surgery will enable the surgeon to more accurately remove tumors, thereby reducing the likelihood of post-surgical recurrence. The camera and endoscope will employ a novel molecular imaging technology called Cerenkov Luminescence Imaging (CLI) that enables optical imaging of radiopharmaceuticals. The molecular sensitivity of CLI has the potential to provide the surgeon with a vastly improved tool for detecting malignant tissue during surgery. If the technology is deemed technically and commercially feasible for the clinic, this project will deliver prototypes of a CLI intra-operative camera and a CLI endoscope. The prototypes will be used for pre-clinical testing, testing in a surgical simulator, and improvements to the next phase of product development.

Each year, 45,000 people in the UK are diagnosed with breast cancer, and 12,000 people will die from the disease. Surgery is the primary treatment option for breast cancer, yet for 1 in 5 patients the tumor will recur following surgery. Cancerous tissue hidden in the borders of the tumor resection is the the main contributor to tumor recurrence following surgery. Consequently, there is a tremendous medical need to give surgeons better tools to detect cancerous tissue during surgery. Artemis Diagnostics LTD is developing a novel intra-operative molecular imaging video camera that will enable surgeons to "see" cancerous tissue in real-time during the operation and guide the resection accordingly. The camera can detect molecular signatures of cancer, thereby extending the diagnostic range of the surgeon's vision. Being able to see cancerous tissue during the operation will enable the surgeon to perform more accurate tumor resections. This will lessen the likelihood of tumor recurrence while preserving healthy tissue. In this market research project, we will collect surgeons' feedback on the camera device to refine the system design, estimate the adoption rate, and determine which surgical cases would most benefit from the technology.