Nephrogreen
Research type
Research Study
Full title
An open label cohort study assessing the near infrared fluoroscopic macro and microscopic appearances of paediatric renal parenchyma and tumours following ex-vivo injection of indocyanine green.
IRAS ID
309846
Contact name
Max Pachl
Contact email
Sponsor organisation
Birmingham Women’s & Children’s NHS Foundation Trust
Clinicaltrials.gov Identifier
NCT05735977
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Summary of Research
Fluorescent guided surgery using Indocyanine Green (ICG) is used in adult cancer operations on a routine basis to enable the surgeon to see where the border of the tumour is, or to identify lymph nodes. . The aim of this study is to see if ICG can help us identify exactly where in the kidney the tumour is located. For kidney cancer, ICG does not make the tumour fluoresce, but the inverse occurs. The normal kidney tissue fluoresces, but the tumour doesn't.
The standard approach to paediatric renal tumour is to remove the whole kidney but this difference in fluorescence may enable surgeons to remove just the tumour and leave healthy kidney tissue behind. This study aims to show exactly where the border is between fluorescence and non-fluorescence for all tumour types under the naked eye and the microscope.
It also aims to review if ICG can differentiate between nephrogenic rests, normal kidney and tumour. These are abnormal areas of renal tissue which are difficult to diagnose with current imaging techniques or on tissue biopsy. They look identical to renal tumours both on imaging and on biopsy. If ICG was able to differentiate between these areas, normal parenchyma, and tumour then this would give surgeons a huge advantage in the management of paediatric renal cancer.Summary of Results
Can ICG help surgeons accurately remove kidney tumours?
After finding the ICG dye helpful for kidney cancer lymph nodes in his 2020 project, I wanted to investigate whether ICG could further help kidney cancer patients. This study was to see whether ICG could help surgeons accurately distinguish between tumour and kidney tissue.As a surgeon, I am familiar with the challenges of kidney cancer surgery:
At the moment, there is no ideal way of telling where the tumour stops and the kidney starts.
"We usually find childhood kidney cancers in one kidney only, and the surgical treatment is most often to take out the tumour along with the rest of the kidney. Unfortunately, some children have cancer in both kidneys. In these children, we try to take out only the cancer and leave the normal kidney behind.”Kidneys are vital organs with a number of important roles, including filtering waste from the blood, which is why surgeons try so hard to leave some functioning kidney tissue behind. However, this does increase the risk of leaving stray cancer cells behind, which means a higher chance of relapse and further toxic treatments for the child.
The results of this project were that ICG may help surgeons remove Wilms tumour, a type of kidney cancer: “In this study we were able to inject ICG into the kidney and tumour immediately after it had been removed to see which parts glowed and which parts did not.”
After removing the tumour, we examined the edges of the glowing healthy tissue under a microscope to check if the dye had helped take out all the cancer cells. This showed that ICG could show the difference between the healthy kidney (which glowed) and low to intermediate risk Wilms tumour cells (which didn’t). However, we were surprised to find that high-risk tumours did take up the dye and glow – meaning that this method couldn’t be used for high-risk kidney cancer surgeries. We need to do more work to see why this happens.
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REC name
West of Scotland REC 1
REC reference
22/WS/0138
Date of REC Opinion
19 Oct 2022
REC opinion
Further Information Favourable Opinion