Micro-dosing Indocyanine Green (ICG) in Children

Investigating Micro-dosing of Indocyanine Green (ICG) for Intraoperative Perfusion Assessment in Children.

The goal of this cohort study is to identify the lowest dose of Indocyanine Green (ICG) that achieves satisfactory intra-operative fluorescence for the assessment of gastrointestinal or genitourinary tract perfusion in children.

Study Overview

• Status: Recruiting
• Conditions: Genitourinary Disease; Perfusion; Fluorescence Imaging; Gastrointestinal Tract Disorders
• Intervention / Treatment: Drug: Indocyanine Green (ICG)

Detailed Description

Indocyanine Green (ICG) fluorescence-guided surgery (FGS) can be used to assess gastrointestinal and genitourinary tract perfusion intra-operatively. In adults, the use of ICG has been shown to improve surgical outcomes. ICG is safely used intra-operatively in children, but there is a lack of evidence regarding the lowest clinically useful dose of ICG.

This is a single centre open-label dose escalation study that aims to:

1. identify the minimal clinically useful dose of ICG for intra-operative perfusion assessment in children (0 - 18 years old)
2. assess the safety profile of intra-operative ICG in children
3. characterise the intra-operative fluorescence of ICG in children

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefano Giuliani; Phone Number: 0669 02074059200; Email: stefano.giuliani@gosh.nhs.uk

Study Locations

• United Kingdom
  • London, United Kingdom, WC1N 3JH
    • Recruiting
    • Great Ormond Street Hospital for Children
    • Contact: Stefano Giuliani; Phone Number: 0669 02074059200; Email: stefano.giuliani@gosh.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Children aged ≤18 years of age
• Elective surgery including gastrointestinal or genitourinary tract perfusion assessment

Exclusion Criteria:

• Renal and liver dysfunction
• Active infection
• Coagulopathy
• Complex congenital heart defect
• Previous documented allergy to ICG injection or other iodinated contrast agents
• Patients suffering from hyperthyroidism or autonomic thyroid adenomas
• Premature infants or neonates in whom exchange transfusion is indicated, due to the hyperbilirubinaemia risk
• Concurrent use of sodium bisulphite-containing preparations, such as certain heparin preparations

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Micro-dosing Indocyanine Green (ICG); Multiple dose levels of intravenous Indocyanine Green (ICG) administered intra-operatively. Starting dose will be 10% of standard (for the study institution) and escalated as per protocol.	Drug: Indocyanine Green (ICG); Cohorts will receive 0.01 mg/kg, 0.02 mg/kg, 0.04mg/kg, 0.06 mg/kg, or 0.08 mg/kg intra-venous ICG at surgery. Patients will be consecutively allocated to different doses as per protocol.; Other Names: Verdye by DiagnosticGreen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimum clinically useful dose of ICG in children	Identify the minimum dose of ICG at which intra-operative perfusion assessment is achieveable. Assessment will be based objectively on mean fluorescence intensity and the fluorescence-time curve, and subjectively by the operating surgeon.	60 minutes (intra-operative)
Number of adverse drug events at each dose level	An appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical complications	Intra-operative and early postoperative complications and mortality (defined as an event observed within 30 days after surgery). Frequency and details.	30 days
Post-operative morbidity	Further procedures, complications and mortality occuring within the 30 - 90 day time period (late post-operative complications). Frequency and details.	90 days
Length of stay	Time in hospital post-procedure	90 days

Collaborators and Investigators

• Sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust
• Investigators: Principal Investigator: Stefano Giuliani, Great Ormond Street Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 20, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Imaging; Fluorescence; Indocyanine Green; Pediatric Surgery; Paediatric Surgery; Fluorescence Guided Surgery (FGS); Intra-operative perfusion assessment
• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases; Urogenital Diseases
• Other Study ID Numbers: 23BO01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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