HySTS (Hybrid Sentinel node Tracer Study)
Research type
Research Study
Full title
HySTS - Hybrid sentinel node tracer study. \nICG-99mTc-nanocolloid Hybrid tracer for Sentinel Node Biopsy – technique optimisation study for oral and lung cancer
IRAS ID
126507
Contact name
M McGurk
Contact email
Sponsor organisation
King's College London
Eudract number
2015-000859-24
Duration of Study in the UK
4 years, 5 months, 1 days
Research summary
In early cancer about 25% of patients have tumour spread to the lymph nodes but it is not possible to detect these tiny cancer deposits, even with the most detailed scans. For this reason most patients with early cancer will have all the local lymph nodes removed as a precaution. Consequently 75% of these patients with early disease will have had an unnecessary procedure to protect the 25% with hidden metastasis.\n It is possible to identify and sample the lymph node in which hidden tumour deposits lie, which is a much smaller operation. This procedure is undertaken routinely in breast cancer (sentinel node biopsy, SNB). \nWe have run an international trial of SNB in oral cancer. Fourteen centres across Europe took part in the trial, which is now finished. The results are good but we would like to improve the accuracy of SN identification as there was an error rate of 13%(about 1 in 8 patients with cancer in the lymph nodes had the wrong node chosen for biopsy). A route cause analysis suggested the error was due to technical factors that made it difficult to identify the correct lymph node at surgery. We are already running a new study using 3D navigation to improve the radio-detection of the sentinel node. We are seeking ethical approval to use a combined fluorescent/radio marker which we think will further reduce error by visually lighting up the sentinel node. The fluorescent dye(ICG)is licensed and has been used since 2005 on its own for a number of different indications but it is not routinely used in this country for sentinel node biopsy. The combined marker has been developed and used in the Netherlands Cancer Institute for well over 300 cases without any problems and these data have been published.\n
REC name
London - Westminster Research Ethics Committee
REC reference
16/LO/0310
Date of REC Opinion
7 Apr 2016
REC opinion
Further Information Favourable Opinion