Micro-dosing Indocyanine Green (ICG) in Children

Status Recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06421103
Study type	Interventional
Source	Great Ormond Street Hospital for Children NHS Foundation Trust
Contact	Stefano Giuliani
Phone	02074059200
Email	stefano.giuliani@gosh.nhs.uk
Status	Recruiting
Phase	N/A
Start date	June 2024
Completion date	August 2028

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