Title: Intraoperative hyperspectral imaging for data-driven real-time surgical guidance
Funder: Department of Health and Social Care

Abstract: To address the pressing clinical need of improved surgical precision and patient safety during neurosurgery, we will develop a medical device capable of contact-free, contrast-agent-free, wide-field imaging and real-time tissue characterisation for seamless surgical guidance. Our innovation relies on advancing data-driven hyperspectral imaging (HSI). Even though the ability of HSI to differentiate tissue types and measure tissue characteristics is supported by a relatively large body of scientific evidence, to date, commercial HSI systems are used mainly for tissue healing analysis rather than for surgical guidance. Indeed, existing systems are slow (20s per image) and lack sterility features vital for surgical guidance. This project builds on our previous research with two successful first-in-patient studies demonstrating that our initial intraoperative HSI (iHSI) prototype seamlessly integrates into the surgical workflow. To deliver on this primary objective, our project will pursue eight aims for our iHSI technology: Demonstrate clinical safety in neurosurgery Establish correlation with histology Develop quantitative perfusion algorithms Achieve clinical-grade wide-field perfusion estimations Demonstrate accurate differentiation of tissue types Advance regulatory compliance towards commercialisation Dissemination of the research to patients and the public Protect innovation and disseminate findings to the research community Our project plan, executed within a 36-month period, is divided into five work packages (WPs) spanning: Clinical implementation (centred on a prospective clinical study involving 81 patients) iHSI hardware design and system characterisation Real-time computational algorithms design Product development following MDR/UKCA-requirements Management, PPI and dissemination The close collaboration between King s College London, King s College Hospital and Hypervision Surgical Ltd (King's spin-out) will ensure a fast-tracked conversion from a healthcare innovation into a product achieving accelerated patient and public benefit. By the end of the project, our technology will be ready for MHRA submission and for inclusion in prospective clinical efficacy studies.

Lay abstract: Brain surgery operations include brain tumour removal and blood vessel procedures. Each year in the UK, approximately 70,500 patients are diagnosed with a brain tumour, 5,000 of whom undergo surgery. Approximately 1,000 patients undergo blood vessel brain surgery. Brain tumour surgery involves removing as much of the tumour as safely as possible. If all tumour is removed, patients have significantly better outcomes and live longer. However, even with the best hands and the most modern technology currently available, it is often not possible to reliably identify tumour during surgery. Moreover, nerves and blood vessels cannot be reliably identified either during surgery. Yet, they need to be preserved to avoid brain damage. Due to this uncertainty and the need to balance risks, tumour is often left behind. Today, close to 30% of brain tumour patients require repeat surgery owing to tumour left behind during their first surgery. Further surgeries are more difficult, pose additional patient risks and lead to increased healthcare costs with often poor patient outcomes. Newly developed camera systems have the potential to enhance the surgeon s vision to reliably identify tumour and healthy brain structures. Hyperspectral imaging (HSI) is one of the most promising of such technologies. Its core ability is to provide very detailed and rich information that is invisible to the human eye. HSI has demonstrated the potential to provide crucial, but currently unavailable, information about tumour and critical brain structures during surgery. However, HSI data is very complex and requires advanced computer-processing for its interpretation. In two previous clinical studies, we have shown that we can safely integrate our HSI prototype system during surgery. In this project, we will further advance our prototype, refine our setup and develop key computer-processing features. We will assess our system in a new clinical study involving 81 patients undergoing brain tumour and blood vessel surgery. The outcomes of this study will inform the commercialisation of the technology for patient and NHS benefits. This study has been designed with patient input and feedback from various patient groups including the Brain Tumour Charity. We received feedback stating that this research in improving surgical outcomes is potentially life-changing, drastically improving patient health, wellbeing and quality of life. The study will form a Patient Advisory Group to advise on all stages of the research. A patient representative, named public co-applicant on the project team, will sit on the study management board. We will ensure that the patient voice is expressed clearly in study reports and when sharing research updates more widely. Results will be made publicly available through publication of open-access research papers, presentation of results at scientific meetings, patient events, and online via King s College London and relevant charity websites/social media.

Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES;6.4 SURGERY;4.1 DISCOVERY AND PRECLINICAL TESTING OF MARKERS AND TECHNOLOGIES
Health categories: CANCER AND NEOPLASMS