King's College London

A consortium of researchers, clinicians, and industry partners have received an NIHR invention for innovation (i4i) product development award to support a clinical neurosurgery study and quality management system led product development for an intraoperative hyperspectral imaging (HSI) technology, designed to make brain tumour removal surgery safer and more complete. The award will allow the team to further develop an existing intraoperative prototype system to achieve commercial readiness with patient input and feedback from patient groups, while also informing on NHS benefits.

Through the course of the 3-year project involving the School of Biomedical Engineering & Imaging Sciences, King’s College Hospital and King’s College London spin-out Hypervision Surgical Ltd, the team will ultimately demonstrate clinical safety of the intraoperative HSI system for neurosurgery involving 81 patients – 18 neurovascular and 63 neuro-oncology patients – undergoing brain tumour and blood vessel surgery.

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. For surgeons, the complication lies in reliably identifying and distinguishing between tumour, healthy brain structures as well as nerve and blood vessels. Often, tumour is left behind resulting in repeat 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 such as HSI can aid surgeons in more reliably and safely identifying and removing tumour as it aims to provide currently unavailable detailed information that is otherwise invisible to the human eye during surgery.

Previously in a clinical feasibility case study and ex-vivo study, it was demonstrated that the research system seamlessly integrates into an operating workflow, with minimal disruption to surgery.

Each study provided crucial insights to develop a system suitable for acquiring high-quality data in a highly dynamic and constrained environment as it is in an operating room during surgery.

This project will further advance the prototype, refine the setup and develop key computer-processing features as HSI data is very complex and requires advanced computer-processing for its interpretation.

As part of a 2-year clinical study, the team will collect comprehensive intraoperative HSI data ranging from healthy brain structures to multiple brain tumour types which can be retrospectively correlated with histological analysis of excised tumour tissue.

This will allow capture of clinical safety data of the system in addition to the creation of paired data vital for developing machine learning-based algorithms for both tissue property and type estimations.

The study also involves patient input and feedback from patient groups, forming a Patient Advisory Group to advise on all stages of the project.

By the end of the project, the technology will be ready for MHRA submission and for inclusion in prospective clinical efficacy studies.

This project is funded by the National Institute for Health Research (NIHR) i4i Product Development Award. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.