Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2024-06-30
2028-08-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Micro-dosing Indocyanine Green (ICG)
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Elective surgery including gastrointestinal or genitourinary tract perfusion assessment
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Great Ormond Street Hospital for Children NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Stefano Giuliani
Role: PRINCIPAL_INVESTIGATOR
Great Ormond Street Hospital
Locations
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Great Ormond Street Hospital for Children
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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23BO01
Identifier Type: -
Identifier Source: org_study_id
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