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NCT Number: NCT06421103

Micro-dosing Indocyanine Green (ICG) in Children

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.

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Key information

Conditions

Perfusion Digestive System Diseases Fluorescence Imaging Gastrointestinal Tract Disorders Genitourinary Disease Urogenital Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Great Ormond Street Hospital for Children

London, WC1N 3JH, United Kingdom

Location status: Recruiting

Location contact

Stefano Giuliani

CONTACT

[email protected]

02074059200 ext. 0669

About this study

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:

  • identify the minimal clinically useful dose of ICG for intra-operative perfusion assessment in children (0 - 18 years old)
  • assess the safety profile of intra-operative ICG in children
  • characterise the intra-operative fluorescence of ICG in children

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indocyanine Green (ICG)

Drug

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 names: Verdye by DiagnosticGreen

Primary outcomes

  1. Minimum clinically useful dose of ICG in children

    Time frame: 60 minutes (intra-operative)

    Identify the minimum dose of ICG at which intra-operative perfusion assessment is achieveable. Assessment will be based objectively on mean fluorescence intensity and the fluorescence-time curve, and subjectively by the operating surgeon.

  2. Number of adverse drug events at each dose level

    Time frame: 30 days

    An appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product

Secondary outcomes

  1. Surgical complications

    Time frame: 30 days

    Intra-operative and early postoperative complications and mortality (defined as an event observed within 30 days after surgery). Frequency and details.

  2. Post-operative morbidity

    Time frame: 90 days

    Further procedures, complications and mortality occuring within the 30 - 90 day time period (late post-operative complications). Frequency and details.

  3. Length of stay

    Time frame: 90 days

    Time in hospital post-procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Stefano Giuliani

CONTACT

[email protected]

02074059200 ext. 0669

Sponsors and collaborators

Lead sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

Other

Registry information

Official study title

Investigating Micro-dosing of Indocyanine Green (ICG) for Intraoperative Perfusion Assessment in Children.

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
May 20, 2024
Registry last updated
May 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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