NCT04854018

Brief Summary

Indo-cyanine green (ICG) is a dye that has been used for a variety of adult and paediatric uses since 1956. Over the past few years, near infrared (NIRF) technology has been developed which allow is use as a fluorescence agent during surgery. It has been used increasingly in the field of adult oncology surgery and has been shown to increase the efficacy of this surgery. The aim of this study is to evaluate the use of NIRF and ICG during specific minimally invasive surgery (MIS) procedures within paediatric oncology surgery. Their use will complement existing surgical techniques rather than replace them. Given the published advantages in adults this study aims to provide evidence of feasibility in the paediatric patients with cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 22, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

April 30, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

August 14, 2023

Status Verified

April 1, 2022

Enrollment Period

1.4 years

First QC Date

February 5, 2021

Last Update Submit

August 9, 2023

Conditions

Pediatric Renal TumorMetastatic OsteosarcomaMetastatic Ewing SarcomaPulmonary MetastasisRhabdomyosarcomaNon-Rhabdo. Soft Tissue Sarcoma

Keywords

Indocyanine greenNear Infra-red fluoroscopypediatriconcologyminimal access surgeryWilms

Outcome Measures

Primary Outcomes (3)

  • Number of fluorescent nodes resected during minimally invasive tumour nephrectomy

    Number of fluorescent nodes resected per patient

    Until the end of surgery, 2 hours

  • Is Fluorescent guided tumour resection easier than non-fluorescent guided.

    Subjective surgeon analysis of intra-operative conditions on a Likert scale per patient

    until the end of surgery, 2 hours

  • To evaluate if NIRF and ICG allow detection of pulmonary metastases

    Comparison of number of lesions seen on CT with those seen with fluoroscopy per patient

    until the end of surgery, 2 hours

Secondary Outcomes (1)

  • To evaluate if fluorescent nodes or metastases are more likely to contain viable tumour

    until histopathology is reported, 2 weeks

Study Arms (1)

Single Arm

EXPERIMENTAL

Injection of Indocyanine Green at doses detailed on summary of product characteristics for each age range

Drug: Indocyanine green

Interventions

Indocyanine greenDRUG

Intravenous or intraparenchymal injection

Also known as: Verdye, Diagnostic Green
Single Arm

Eligibility Criteria

Age1 Day - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age between 1 day and 15 years 365 days
  • Have a diagnosis of an intra-abdominal, retroperitoneal or intra-thoracic tumour or pulmonary metastases
  • Require surgery as part of their treatment
  • Tumour or metastasis suitable for MIS resection based on assessment of the pre-operative imaging

You may not qualify if:

  • Allergic to ICG
  • Allergic to iodine or iodides
  • Due to receive radioactive iodine as part of a treatment
  • Hyperthyroidism
  • Unwilling to participate
  • Chronic Kidney Disease stage V

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Birmingham children's hospital

Birmingham, B4 6NH, United Kingdom

Location

Related Publications (1)

  • Pachl MJ. Fluorescent Guided Lymph Node Harvest in Laparoscopic Wilms Nephroureterectomy. Urology. 2021 Dec;158:189-192. doi: 10.1016/j.urology.2021.09.015. Epub 2021 Oct 2.

    PMID: 34606881DERIVED

MeSH Terms

Conditions

OsteosarcomaSarcoma, EwingRhabdomyosarcomaSarcomaNeoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Neoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeMyosarcomaNeoplasms, Muscle Tissue

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Max Pachl

    Birmingham Women's and Children's NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: open label, single centre, single arm, prospective feasibility study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2021

First Posted

April 22, 2021

Study Start

April 30, 2021

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

August 14, 2023

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)