Micro-dosing Indocyanine Green (ICG) in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Indocyanine Green (ICG).
- Who it may be relevant to
- Registry conditions: Perfusion, Fluorescence Imaging, Gastrointestinal Tract Disorders, Genitourinary Disease. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Investigating Micro-dosing of Indocyanine Green (ICG) for Intraoperative Perfusion Assessment in Children.
Overview
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
Interventions
- 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.
Primary outcome measures
- Minimum clinically useful dose of ICG in children [Time frame: 60 minutes (intra-operative)]
- Number of adverse drug events at each dose level [Time frame: 30 days]
Secondary outcome measures (3)
- Surgical complications [Time frame: 30 days]
- Post-operative morbidity [Time frame: 90 days]
- Length of stay [Time frame: 90 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United Kingdom · 1 center
- Great Ormond Street Hospital for Children — London
Identifiers
NCT: NCT06421103 · 23BO01