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
- Diseases
- Kidney cancer, Childhood cancers
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Birmingham Children's Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.