GLO-Surgery
Research type
Research Study
Full title
Indocyanine Green and near infrared fLuorescence in paediatric Oncology surgery
IRAS ID
1008320
Contact name
Max Pachl
Contact email
Sponsor organisation
University of Birmingham
ISRCTN Number
ISRCTN26150156
Research summary
Surgery is a vital part of the treatment for many young people with cancer but does not always go as planned.
Parts of the tumour can be left behind or missed and other organs can be damaged as the surgeon tries to get all the tumour out. The cancer may have also spread to the lymph nodes, which can be removed to look for disease. However, lymph nodes can be difficult to find. Sometimes tissue which looks like lymph nodes is removed but turns out not to be when checked under the microscope.
We want to test if using a dye called Indocyanine Green (ICG) can help surgeons identify the tumour and lymph nodes during surgery. This is called fluorescent guided surgery (FGS). ICG is a dye which becomes fluorescent when looked at with near infra-red light (NIR) from special cameras. It can be injected into the bloodstream before surgery and collects within the tumour. This means the surgeon can see exactly where the tumour is making it easier to remove all of it and limit damage to normal organs. ICG can also be injected directly into the tissue where the tumour is growing to see if it appears in lymph nodes nearby. This makes them easier to see and remove.
This trial will include children and adults with a tumour located in their chest area, or in their abdomen (tummy), or a tumour which has spread to the lungs (pulmonary metastasis) which needs surgery. Half of the patients will receive ICG, and half will not. The decision who gets the dye will be made at random by a computer. This is so that the results can show a difference (if there is one) which is not influenced by anyone. Patients with para-testicular rhabdomyosarcoma (pt-RMS) will all receive the ICG as this is a rare type of cancer and there will not be enough patients to split between two groups.
The results will show if using the dye (ICG) makes surgery easier, better, and safer.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
24/NE/0098
Date of REC Opinion
26 Jul 2024
REC opinion
Further Information Favourable Opinion