LEAN · Morphomolecular diagnostics of head and neck cancer

Head and neck cancers (HNC) represent a significant global health burden and have poor survival rates when diagnosed at advanced stages. Early detection at precancerous or early cancer stages is the most effective strategy to reduce mortality, improve patient outcomes and save healthcare expenses. However, current endoscopic approaches are limited in their ability to provide accurate diagnosis, monitoring and timely intervention. Building upon patented ERC research, the LEAN project addresses this critical clinical gap by exploring the commercial application of a ground-breaking multi-modal endoscopic platform that integrates Raman spectroscopy with optical coherence tomography (OCT) within a single miniaturised (<2.2 mm) fibre-based probe. This innovative combination harnesses the unparalleled molecular specificity of Raman spectroscopy alongside the high-resolution morphological imaging capabilities of OCT, offering clinicians a powerful new tool for real-time, non-invasive detection, grading and staging of HNC. Here we will optimise and refine the fabrication process and develop a rigorous quality and manufacturing system (QMS) design file. These advancements will ensure safety and scalable assembly for prospective clinical trials. The project will also leverage artificial intelligence (AI) to synergistically fuse Raman and OCT datasets, enabling the creation of robust algorithms capable of delivering real-time probabilistic diagnosis of precancer and cancer. LEAN lays the groundwork for exploitation of our innovation by outlining a project that will enable translation of our device into humans to ultimately change the current clinical pathway for H&N patients. These activities pave for the for clinical trials and will provide an entry point in the broader market for label-free minimally invasive diagnostics.