Surgeons are injecting a fluorescent dye into sarcoma patients to see, in real time, whether any cancer cells remain at the edge of the tumour after removal. Around 5,300 people are diagnosed with sarcoma in the UK each year, and surgery is the main treatment. In roughly one in five cases, standard surgery leaves behind microscopic cancer cells at the tumour margin—a positive margin that raises the risk of recurrence and death. No randomised trial has ever tested a purely surgical intervention for sarcoma. This trial will directly compare fluorescence-guided surgery against standard care in 30 UK centres, using histopathology to confirm whether the dye helps surgeons achieve clean margins more consistently. If fluorescence guidance reduces the unexpected positive margin rate, it could become a new standard technique for sarcoma surgery. That would mean fewer patients needing repeat operations, radiotherapy, or chemotherapy—and potentially better long-term survival. The trial will also map where fluorescence accumulates in tissue, clarifying how the technique works at a microscopic level.
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Research question Does fluorescence guided surgery significantly reduce the unexpected positive margin rate compared to standard surgery in patients undergoing open surgery for sarcoma? Background Sarcomas arise from soft tissues and bone, accounting for 1% of all cancers with around 5300 new diagnoses annually in the UK. The 5 year survival rate is poor at approximately 65%. Surgery is the mainstay of treatment with the aim of resection of the sarcoma with a negative margin implying that there is no disease left in the patient. A positive margin means there are sarcoma cells visible at the edge of the tumour. The sarcoma is also assigned a grade. High grade sarcomas have an increased positive margin rate which is linked to adverse outcomes. No randomised controlled sarcoma trials with a purely surgical intervention have ever been conducted. The National Cancer Research Institute Sarcoma Research Group has reached a consensus that trials in surgery are a priority to assess new technologies that may improve surgical performance. Fluorescence guided surgery is a promising technique that holds potential for improving surgical performance to reduce positive margin rates and thereby improve outcomes for our sarcoma patients. Aims and objectives • To conduct a RCT to compare the efficacy of fluorescence guided surgery versus standard surgery in reducing the unexpected positive margin rate • To determine the impact of fluorescence guided surgery on clinical and patient focussed outcomes over a one year period • To understand the mechanism of fluorescence guided surgery by conducting histopathological and fluorescence mapping sub-studies Methods, including justification of study design Careful consideration was given to the trial design with input from our PPI group and sarcoma centres around the UK. The following was agreed: a prospective, 2 arm, randomised, open label, multi-centre trial to establish the efficacy of fluorescence guided surgery in reducing the unexpected positive margin rate in patients undergoing surgery for sarcoma. Consenting patients who fulfil the eligibility criteria will be randomised to receive fluorescence guided resection (intervention arm) or standard resection (control arm) in a 1:1 ratio. Efficacy will be established using histopathological samples collected during surgery, and analysed in histopathology laboratories at participating centres to understand microscopic tumour infiltration into tissue (margin) beyond the tumour boundary. Timelines for delivery Total duration is 58 months with a proposed start date of 01 October 2022. Months 1-7 full protocol development, government approvals, contracting and site set up. Months 8-37, for 30 months recruitment. Data collection will close at the end of month 52. Months 53-58 data analysis, final report and dissemination. Anticipated impact and dissemination Trial results will be shared widely, including with patient groups, charities and presented at national and international meetings. We will also publish the main trial findings and the results of the associated sub-studies in leading open access medical journals. We will undertake a series of PPIE meetings at the end of the trial to understand the experience of taking part for patients, and to ensure that our interpretation, and dissemination plan maintains its focus on patients.
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