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NCT05735977Completed

Nephrogreen. Appearances of Exvivo Renal Tumours Under Near-infrared

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

Source: ClinicalTrials.gov · Last updated 4 Mar 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
12 (actual)
First submitted
20 Dec 2022
Start date
1 Feb 2023
Primary completion date
6 Jan 2025
Lead sponsor
Birmingham Women's and Children's NHS Foundation Trust
NCT number
NCT05735977

What you commit to

  • Study type: Interventional
  • Participants enrolled: 12
  • From 1 Feb 2023 to the primary completion date, 6 Jan 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Tumour removed in multiple pieces
  • Renal vein thrombus

Who the study is looking for

  • Diagnosis of paediatric renal tumour
  • A requirement for radical total nephroureterectomy as part of the treatment

Age in the registry: 1 day to 15 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Birmingham Children's Hospital
Coordinator of this site? Confirm its status
BirminghamUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.