Nephrogreen. Appearances of Exvivo Renal Tumours Under Near-infrared (Nephrogreen)

February 9, 2023 updated by: Birmingham Women's and Children's NHS Foundation Trust

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will ascertain if paediatric renal tumours are ICG avid or not. This is critical for determining what the value of using ICG/NIRF will be during nephron sparing surgery (NSS)/ partial nephrectomy in children who have renal tumours that are suitable for this type of surgery. If the normal renal parenchyma is ICG avid but the tumour is not (as has been shown for RCC in adults) then we can conclude that if a fluorescent margin left in-situ on the tumour, then it would be completely resected. Early work at St. Jude has suggested this technique shows promise, but it has not been validated prospectively at a macro or microscopic level.

This is important because in children with unilateral tumours, total nephrectomy has been performed routinely due to concern over leaving behind tumour tissue. If tumour tissue is left behind the patient is upstaged and requires radiotherapy with the consequent sequelae that confers. Radiotherapy to this area invariably damages the kidney so much that it is essentially non-functioning and avoiding this exposure would clearly be ideal. In children with bilateral tumours, retaining as much renal tissue as possible whilst facilitating a complete resection is the goal of surgery. If ICG/NIRF can help with this then it will change the game for this population of patients In addition, this technique will aid in retaining as much normal parenchyma as possible giving the patient better long-term outcomes for renal function. As a further advantage, the study may ascertain if ICG can differentiate between non-cancerous nephrogenic rests (NRs), normal renal parenchyma, and tumour. The difference between these types of tissue is critical when doing NSS because currently only formal histopathological assessment can reliably differentiate NRs from normal tissue or tumour. This is because the definition hinges on whether the lesions have a capsule or not. This is not identifiable on imaging or on core biopsy. The vital feature is that NR's do not require resection, whereas tumour obviously does.

Avidity for ICG may be different in different types of tumours and this will be recorded using the intensity mapping feature of the Storz Rubina Opal1 system. At a cellular level it will be important to investigate why ICG does not cross into tumour and whether this is due to the tumour capsule preventing or limiting vascular flow, or some other factor.

ICG does not affect the histopathological assessment and this research study will validate whether ICG survives the fixing process as this has not been assessed with an NIR capable microscope.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B4 6NH
        • Birmingham children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Tumour removed in multiple pieces
  • Renal vein thrombus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Indocyanine Green
Cohort study using one arm, no comparator group is possible or feasible
Diagnostic test: Indocyanine Green (ICG)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Macroscopic appearance
Time Frame: Immediately following tumour resection
Macroscopic comparison assessment of ICG avidity using Storz Rubina NIR between normal renal parenchyma and tumour.
Immediately following tumour resection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICG intensity mapping
Time Frame: Immediately following tumour resection
Measurement of the quantifiable level of avidity using intensity mapping on a Karl Storz Endoskope™ Opal 1 Rubina system.
Immediately following tumour resection
Microscopic appearance
Time Frame: Within 2 weeks following tumour resection
Microscopic comparison of ICG avidity between tumour, non-tumour and nephrogenic rests using a nearinfrared microscope.
Within 2 weeks following tumour resection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Birmingham Women's and Children's NHS Foundation Trust

Collaborators

Children's Cancer and Leukaemia Group

Investigators

  • Principal Investigator: Max Pachl, Birmingham Women's and Children's NHS Foundation Trust, UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

December 20, 2022

First Submitted That Met QC Criteria

February 9, 2023

First Posted (Estimate)

February 20, 2023

Study Record Updates

Last Update Posted (Estimate)

February 20, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22/BC/ONC/NO/655

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

all IPD that underlie results in a publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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