A new optical instrument will scan breast cancer patients’ lymph nodes during surgery, giving surgeons a yes-or-no answer on cancer spread within 10 minutes. Currently, women with breast cancer often wait one to two weeks for lab results on their sentinel lymph node biopsies. Around 20% of these biopsies come back positive, requiring a second operation to remove additional lymph nodes. That second surgery raises the risk of chronic arm swelling, shoulder problems, and nerve damage. The integrated autofluorescence-Raman spectroscopy (AF-Raman) system combines two light-based techniques with machine learning to detect metastatic cells without destroying the tissue. In a pilot study, it achieved 80% sensitivity and 97% specificity. If the prototype matches those results across 120 patients at the Nottingham Breast Institute, surgeons could remove affected nodes in a single procedure, sparing patients a second operation and reducing NHS costs. The technology is non-destructive, so standard histology can still confirm the diagnosis afterward. The same platform could eventually be adapted for skin, colorectal, gynaecological, and prostate cancers—roughly 250,000 UK patients per year.
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Background Sentinel lymph node (SLN) biopsy is a standard procedure for patients with breast cancer. A negative SLN diagnosis eliminates the need for axillary lymph node clearance (ALNC), which is associated with increased morbidity such as lymphedema, shoulder dysfunction, injury to axillary vein and motor nerves. Contrasting this, positive SLNs confirmed by histological examination (which can take 1-2 weeks) are typically followed by a second axillary operation. SLNs are found positive on histopathological examination in around 20% of cases. An instrument that can diagnose positive SLNs intra-operatively would allow immediate ALNC during the initial breast resection surgery. One step nucleic acid amplification (OSNA) can be used intraoperatively and detects positive nodes with ~87% sensitivity and 92-98% specificity, but the test consumes the tissue and thus compromises histology evaluation. In a proof-of-concept study we showed that integrating autofluorescence (AF) imaging and Raman spectroscopy modules on a single microscope allowed scanning of individual lymph nodes within 20-30 minutes and detected metastatic nodes with 80% sensitivity and 97% specificity. Unlike OSNA, the AF-Raman measurements are non-destructive, meaning that the SLNs can be analysed by histology after the measurement, for confirmation or for other treatment decisions. Aims and Objectives The main aim of this project is to develop a regulatory compliant AF-Raman prototype and generate proof-of-concept data in the clinic to estimate accuracy and support its adoption in the NHS. Specific objectives: 1. Develop an optimised AF-Raman instrument. 2. Integrate the AF-Raman instrument in the clinical pathway at the Nottingham Breast Institute. 3. Test the instrument on SLN biopsies (120 patients) to assess diagnostic accuracy. 4. Ensure the research remains patient centred. 5. Develop a viable implementation strategy and pathway to impact. Methods We will build a unique combined system using an optimised AF scanning procedure that integrates Raman measurements to analyse SLN biopsies within 10 minutes (maximum acceptable 30 minutes) and machine learning algorithms to deliver quantitative diagnosis without destroying the samples. The AF-Raman prototype will be integrated in the operating theatre at the Nottingham Breast Institute and will be tested on using SLN biopsies from at least 120 patients undergoing breast cancer surgery. The results of the AF-Raman assessment (SNL biopsy positive: YES/NO) will be compared to postoperative histology (reference standard), providing estimates of sensitivity and specificity. In parallel, we will develop the commercialisation strategy and plans for follow up NHS adoption and implementation. Timelines for delivery Instrument development (months 1-12), clinical integration (months 13-18), performance evaluation (months 19-30), commercialisation and clinical translation (months 1-30). Anticipated impact and dissemination The AF-Raman system will lead to a step-change in breast cancer surgery: surgeons could detect positive SLNs while the patient is in the operating room, allowing, if needed, axillary lymph node clearance in a single operation. Second surgery leads to poorer outcomes for patients, long recovery times and higher healthcare costs. The AF-Raman is a platform technology and may be applicable to other major cancers, including skin, colorectal, gynaecological and prostate cancers (total ~250,000 patients per year in the UK).
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