Micro-dosing Indocyanine Green (ICG) in Children

Perfusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06421103
• Other study ID #: 23BO01
• Status: Recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: August 2028

Study information

• Verified date: May 2024
• Source: Great Ormond Street Hospital for Children NHS Foundation Trust
• Contact: Stefano Giuliani
• Phone: 02074059200
• Email: stefano.giuliani[@]gosh.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 2028
• Est. primary completion date: August 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases
• Genitourinary Disease
• Perfusion
• Urogenital Diseases

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Great Ormond Street Hospital for Children	London

Sponsors (1)

Lead Sponsor	Collaborator
Great Ormond Street Hospital for Children NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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
Secondary	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
Secondary	Length of stay	Time in hospital post-procedure	90 days