Full title
SarcoSIGHT – A randomised controlled trial of fluorescence guided sarcoma surgery versus standard of care.
Background
Sarcomas are cancers usually affecting an arm or a leg, arising from childhood to old age, with many occurring in younger people. Every sarcoma is different.
Patients with a sarcoma can be referred to an orthopaedic or plastic surgeon with expertise in treating these cancers. Scans help to plan the operation to remove healthy tissue around the tumour to reduce the risk of the tumour coming back. How much healthy tissue to remove is decided during the operation.
The tumour is then assessed by a pathologist and if it is completely encased in healthy tissue (clear margins) the likelihood of the sarcoma coming back is reduced. However, removing healthy tissue can leave patients with disability and pain that has a lifelong impact.
New technologies in surgery can help more precise operations, reducing the need for wider margins.
The North of England Bone & Soft Tissue Tumour Service in Newcastle upon Tyne have pioneered the use of indocyanine green (ICG), a harmless dye, along with a special ‘infrared’ camera. The sarcoma glows on the TV screen when seen by the camera during the surgery. Results from the first 38 operations using the new technology have been promising.
What we are doing
The aim of this study is to determine whether the use of ICG and the infrared camera can benefit patients by ensuring clear margins during surgery, making cancer recurrence less likely and reducing adverse impacts (e.g., disability and pain) of the surgery on quality of life.
Patient groups have helped to develop the study. This included discussing the study design and agreeing on the acceptability of the randomisation element. Half of the patients in the study will undergo surgery without the use of the dye and the infrared camera. The other half will receive the dye and will use the camera.
We will measure how much healthy tissue surrounds each tumour to see whether the technology helps the surgeon to remove the best margin of normal tissue.
We will follow up with patients up to 1 year and 5 years after their operation to check the long-term results.
We will also look at how different types of sarcoma take up the ICG dye and conduct tests on alternative camera systems.
Chief investigator
Mr Kenneth Rankin
Co-lead
Professor Amar Rangan
Funder
NIHR EME
Study status
In set-up