A new optical instrument called Fast-Raman will scan the edges of freshly removed skin cancers while the patient is still on the operating table, checking whether any tumour cells remain behind. Around 150,000 people in the UK are diagnosed with basal cell carcinoma each year. For large or facial tumours, the standard treatment is wide local excision, but the surgeon cannot tell during the operation whether the margins are clear. Patients then wait two to four weeks for histology results, often needing a second surgery if cancer remains. Only about 10 per cent of eligible patients can access Mohs micrographic surgery, which checks margins in real time, because the service is patchy across the NHS. If Fast-Raman proves accurate, surgeons could detect incomplete margins immediately and remove more tissue in the same operation. That would spare patients the anxiety of waiting and reduce NHS costs from repeat surgeries and follow-up appointments. The team will test the instrument on 170 excised tissue samples, comparing its readings against standard histopathology to calculate sensitivity and specificity. A successful proof-of-concept would pave the way for a national multi-centre trial and, ultimately, wider NHS adoption.
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Research Questions Can the Fast-Raman instrument measure the surgical margins during standard local excision of high-risk basal cell carcinoma? What is the level of agreement with histopathology? Background Basal cell carcinoma (BCC) is the commonest human cancer, with approximately 150,000 cases diagnosed annually in the UK. While most BCCs can be removed by standard excision, large BCCs (>2cm) and those on the head and neck are at risk of incomplete removal. The National Institute for Health and Care Excellence recommends that these high-risk patients should be treated by Mohs micrographic surgery whereby sequential skin layers are excised and examined by frozen section histopathology to check surgical margins. If margins are incomplete, the location of residual cancer is recorded and further layers of skin are removed until margins are complete. However, only ~10% of UK patients can access this treatment due to patchy availability within the NHS. The majority of patients who are denied access to Mohs surgery for their high-risk BCC are treated by standard wide local excision and endure anxiety and distress whilst waiting (2-4 weeks) for histopathology results and the potential need for further surgery to remove residual cancer. Aims and Objectives Our main aim is to improve the outcome of BCC surgery by using a new "Fast-Raman" instrument to check the surgical margins during standard excision of high-risk BCC. This project will generate proof-of-concept data from the clinic to estimate the accuracy of Fast-Raman for identifying incomplete surgical margins to inform a follow on definitive multi-centre study in the NHS. Objectives: 1) To calculate the agreement between Fast-Raman and histopathology for high-risk BCCs excised by standard excision and estimate sensitivity/specificity for detection of incomplete and close margins. 2) To develop study protocol for a follow-on national multi-centre diagnostic test accuracy study. Methods We will analyse resected skin samples from 170 patients with high-risk BCC undergoing standard excision. The excised tissue specimens will be first analysed with the "Fast-Raman" instrument to measure the surgical margins and determine whether they are complete or not, and compare the result with standard histopathology (reference) to calculate the level of agreement (kappa) and provide estimates of sensitivity and specificity. In parallel, we will develop the protocol for a follow-on definitive study to determine the accuracy of Fast Raman with a precision required for NHS adoption. Timelines for delivery Clinical integration (months 1-2), performance evaluation (months 2-12), protocol for follow-up definitive study (months 1-12). Anticipated impact and dissemination The Fast-Raman instrument will lead to a step-change in BCC surgery: incomplete surgical margins could be detected while the patient is in the operating room, allowing surgeons to excise additional tissue until the entire BCC is removed. Thus, patients will be cured in a single operation, reducing anxiety whilst waiting for histology results, and reduce NHS follow-up appointments and costs for re-operations. We will report the results to the scientific and medical conferences and will work with our patient advisory group to present the project more broadly to patients and the public.
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