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NCT05735977
Nephrogreen. Appearances of Exvivo Renal Tumours Under Near-infrared
Conditions: Wilms Tumor, Renal Cancer
Sex: All
Ages: 1 Day – 15 Years
Phase: NA
Enrollment: 20
Sponsor: Birmingham Women's and Children's NHS Foundation Trust
Location: United Kingdom
Summary
Indocyanine Green (ICG) is a dye which fluoresces under near-infrared (NIR) light.
It has been used for several applications in adult surgery.
The CI is pioneering its use in children's kidney cancer surgery for lymph node identification and removal.
This study concentrates on its use for procedures where only the part of the kidney containing tumour is removed.
It is known that kidney tumours in both adults and children do not take up ICG at all.
This absence of uptake can be used to define the border between normal and abnormal renal tissue giving a real-time picture of the area of tumour.
This then delivers surgeons an intra-operative roadmap for removing only the cancerous part of the kidney.
At present the international society of paediatric oncology - renal tumour study group (SIOP-RTSG) protocol, which is followed in the UK, advises consideration of partial nephrectomy for children with bilateral renal tumours and in children with unilateral tumours who have a renal tumour predisposition syndrome.
There is ongoing debate about partial nephrectomy in unilateral renal tumour surgery in children who do not have a predisposition syndrome.This study aims to provide the evidence that paediatric renal tumours do not take up ICG at a naked-eye level and confirm this at a cell level.
ICG will be infused into kidneys containing tumour once they have been removed from the patient, The kidney and tumour will be observed under NIR light to show where the areas of fluorescence are.
Then, a pathologist will prepare the specimen in theatre, in the same way they would do in the lab.
The specimen would be bivalved and reviewed under NIR.
Microscopy specimens of the border between normal and abnormal tissue would then be reviewed with an NIR capable microscope.
The standard histopathological assessment would then take place.
Eligibility Criteria
Inclusion Criteria:Diagnosis of paediatric renal tumourA requirement for radical total nephroureterectomy as part of the treatmentExclusion Criteria:Tumour removed in multiple piecesRenal vein thrombus
Source: ClinicalTrials.gov (NCT05735977). StuddyBuddy aggregates publicly available trial information.