Nephrogreen. Appearances of Exvivo Renal Tumours Under Near-infrared

NCT05735977 | Completed

• 1 other identifier: 22/BC/ONC/NO/655
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wilms Tumor; Renal Cancer

Keywords

Wilms; Indocyanine Green; Partial Nephrectomy

Outcome Measures

Primary Outcomes (1)

• Macroscopic appearance

  Macroscopic comparison assessment of ICG avidity using Storz Rubina NIR between normal renal parenchyma and tumour.

  Immediately following tumour resection

Secondary Outcomes (2)

• ICG intensity mapping

  Immediately following tumour resection

• Microscopic appearance

  Within 2 weeks following tumour resection

Study Arms (1)

Indocyanine Green

OTHER

Cohort study using one arm, no comparator group is possible or feasible

Diagnostic Test: Indocyanine Green (ICG)

Interventions

Indocyanine Green (ICG) DIAGNOSTIC_TEST

Will the use of ICG delineate the margin between normal kidney parenchyma and renal tumour in children at a macroscopic level and can this be replicated at a microscopic level

Indocyanine Green

Eligibility Criteria

• Age: 1 Day - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Tumour removed in multiple pieces
• Renal vein thrombus

Sponsors & Collaborators

• Birmingham Women's and Children's NHS Foundation Trust: lead
• Children's Cancer and Leukaemia Group: collaborator

Study Sites (1)

Birmingham children's hospital

Birmingham, B4 6NH, United Kingdom

Location

Related Publications (13)

• van den Bos J, Wieringa FP, Bouvy ND, Stassen LPS. Optimizing the image of fluorescence cholangiography using ICG: a systematic review and ex vivo experiments. Surg Endosc. 2018 Dec;32(12):4820-4832. doi: 10.1007/s00464-018-6233-x. Epub 2018 May 18.

  PMID: 29777357 BACKGROUND

• Farag S, Frazzini Padilla P, Smith KA, Flyckt R, Sprague ML, Zimberg SE. Fallopian tube perfusion in ex-vivo and in-vivo laparoscopic hysterectomy specimens: potential application for uterine transplantation. Hum Reprod. 2018 Dec 1;33(12):2232-2240. doi: 10.1093/humrep/dey307.

  PMID: 30304437 BACKGROUND

• Vujanic GM, Gessler M, Ooms AHAG, Collini P, Coulomb-l'Hermine A, D'Hooghe E, de Krijger RR, Perotti D, Pritchard-Jones K, Vokuhl C, van den Heuvel-Eibrink MM, Graf N; International Society of Paediatric Oncology-Renal Tumour Study Group (SIOP-RTSG). The UMBRELLA SIOP-RTSG 2016 Wilms tumour pathology and molecular biology protocol. Nat Rev Urol. 2018 Nov;15(11):693-701. doi: 10.1038/s41585-018-0100-3.

  PMID: 30310143 BACKGROUND

• Dome JS, Fernandez CV, Mullen EA, Kalapurakal JA, Geller JI, Huff V, Gratias EJ, Dix DB, Ehrlich PF, Khanna G, Malogolowkin MH, Anderson JR, Naranjo A, Perlman EJ; COG Renal Tumors Committee. Children's Oncology Group's 2013 blueprint for research: renal tumors. Pediatr Blood Cancer. 2013 Jun;60(6):994-1000. doi: 10.1002/pbc.24419. Epub 2012 Dec 19.

  PMID: 23255438 BACKGROUND

• Mitsui Y, Shiina H, Arichi N, Hiraoka T, Inoue S, Sumura M, Honda S, Yasumoto H, Igawa M. Indocyanine green (ICG)-based fluorescence navigation system for discrimination of kidney cancer from normal parenchyma: application during partial nephrectomy. Int Urol Nephrol. 2012 Jun;44(3):753-9. doi: 10.1007/s11255-011-0120-x. Epub 2012 Jan 4.

  PMID: 22215306 BACKGROUND

• Soga N, Inoko A, Furusawa J, Ogura Y. Evaluation to Differentiate between Tumor Lesions and the Parenchyma in Partial Nephrectomies for Renal Tumors Based on Quantitative Fluorescence Imaging Using Indocyanine Green Dye. Curr Urol. 2019 Oct;13(2):74-81. doi: 10.1159/000499289. Epub 2019 Oct 1.

  PMID: 31768173 BACKGROUND

• Mrad C, Coulomb-Lhermine A, Tabone MD, Ulinski T, Audry G, Irtan S. Evaluation of the nephron-sparing surgery formula in Wilms tumors. Pediatr Blood Cancer. 2020 Dec;67(12):e28661. doi: 10.1002/pbc.28661. Epub 2020 Aug 18.

  PMID: 32808461 BACKGROUND

• Rickard M, Fernandez N, Blais AS, Shalabi A, Amirabadi A, Traubici J, Lee W, Gleason J, Brzezinski J, Lorenzo AJ. Volumetric assessment of unaffected parenchyma and Wilms' tumours: analysis of response to chemotherapy and surgery using a semi-automated segmentation algorithm in children with renal neoplasms. BJU Int. 2020 May;125(5):695-701. doi: 10.1111/bju.15026. Epub 2020 Feb 27.

  PMID: 32012416 BACKGROUND

• Cozzi DA, Ceccanti S, Frediani S, Schiavetti A, Cozzi F. Chronic kidney disease in children with unilateral renal tumor. J Urol. 2012 May;187(5):1800-5. doi: 10.1016/j.juro.2011.12.109. Epub 2012 Mar 17.

  PMID: 22424685 BACKGROUND

• Cozzi DA, Ceccanti S, Cozzi F. Renal function up to the 5th decade of life after nephrectomy in childhood: A literature review. Nephrology (Carlton). 2018 May;23(5):397-404. doi: 10.1111/nep.13202.

  PMID: 29194872 BACKGROUND

• Green DM, Wang M, Krasin MJ, Davidoff AM, Srivastava D, Jay DW, Ness KK, Shulkin BL, Spunt SL, Jones DP, Lanctot JQ, Shelton KC, Brennan RC, Mulrooney DA, Ehrhardt MJ, Gibson TM, Kurt BA, Robison LL, Hudson MM. Long-term renal function after treatment for unilateral, nonsyndromic Wilms tumor. A report from the St. Jude Lifetime Cohort Study. Pediatr Blood Cancer. 2020 Oct;67(10):e28271. doi: 10.1002/pbc.28271. Epub 2020 Jul 24.

  PMID: 32706494 BACKGROUND

• Tan XH, Zhang DY, Liu X, Lin T, He DW, Li XL, Wei GH. Retrospective analysis to determine outcomes of patients with bilateral Wilms tumor undergoing nephron sparing surgery: 15-year tertiary single-institution experience. Pediatr Surg Int. 2018 Apr;34(4):427-433. doi: 10.1007/s00383-018-4232-6. Epub 2018 Jan 24.

  PMID: 29368077 BACKGROUND

• Kieran K, Williams MA, Dome JS, McGregor LM, Krasin MJ, Davidoff AM. Margin status and tumor recurrence after nephron-sparing surgery for bilateral Wilms tumor. J Pediatr Surg. 2013 Jul;48(7):1481-5. doi: 10.1016/j.jpedsurg.2013.02.033.

  PMID: 23895958 BACKGROUND

MeSH Terms

Conditions

Wilms Tumor; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Max Pachl

  Birmingham Women's and Children's NHS Foundation Trust, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single centre cohort study using consecutive patients. No comparison group.

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: February 21, 2023
• Study Start: February 1, 2023
• Primary Completion: January 6, 2025
• Study Completion: January 6, 2025
• Last Updated: March 4, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)