Micro-dosing Indocyanine Green (ICG) in Children

Not Applicable

Recruiting

• Conditions: Perfusion; Fluorescence Imaging; Gastrointestinal Tract Disorders; Genitourinary Disease
• Interventions: Drug: Indocyanine Green (ICG)

• Registration Number: NCT06421103
• Lead Sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-01-08
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-15
• Last Update Submitted: 2024-05-15
• Study First Posted: 2024-05-20
• Last Update Posted: 2024-05-20
• Study Start: 2024-06
• Primary Completion: 2028-08
• Study Completion: 2028-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Micro-dosing Indocyanine Green (ICG)	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.

Primary Outcome Measures

Name	Time	Method
Minimum clinically useful dose of ICG in children	60 minutes (intra-operative)	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.
Number of adverse drug events at each dose level	30 days	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Great Ormond Street Hospital for Children; 🇬🇧 London, United Kingdom