Micro-dosing Indocyanine Green (ICG) in Children

NHS Foundation Trust

Status: Enrolling

Conditions: Perfusion; Fluorescence Imaging; Gastrointestinal Tract Disorders; Genitourinary Disease

Treatments: Drug: Indocyanine Green (ICG)

Study type: Interventional

Funder types: Other

Identifiers

NCT06421103

23BO01

Details and patient eligibility

About

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.

Full 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

Enrollment: 90 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

Micro-dosing Indocyanine Green (ICG)

Experimental group

Description:

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.

Treatment:

Drug: Indocyanine Green (ICG)