Using low doses of Indocyanine Green in children during surgery
Investigating Micro-dosing of Indocyanine Green (ICG) for Intraoperative Perfusion Assessment in Children.
This study is testing the lowest safe dose of a dye called Indocyanine Green to see if it can help doctors check blood flow during surgery in children.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Great Ormond Street Hospital for Children NHS Foundation Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06421103 on ClinicalTrials.gov |
What this trial studies
This cohort study aims to determine the lowest effective dose of Indocyanine Green (ICG) for assessing gastrointestinal and genitourinary tract perfusion in children during surgery. It will involve a single center, open-label, dose escalation approach to identify the minimal clinically useful dose while also evaluating the safety profile of ICG in pediatric patients. The study will characterize the intra-operative fluorescence of ICG to improve surgical outcomes in children undergoing elective procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0 to 18 years who are undergoing elective surgery involving gastrointestinal or genitourinary tract perfusion assessment.
Not a fit: Patients with renal or liver dysfunction, active infections, or certain other medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance surgical outcomes for children by optimizing the use of ICG in fluorescence-guided surgery.
How similar studies have performed: Previous studies in adults have shown that ICG can improve surgical outcomes, but this specific approach in children is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
London
- Great Ormond Street Hospital for Children — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Stefano Giuliani — Great Ormond Street Hospital
- Study coordinator: Stefano Giuliani
- Email: stefano.giuliani@gosh.nhs.uk
- Phone: 02074059200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.