Evaluation of the LightPath Imaging System in head and neck cancer surgery

"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."