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Micro-dosing Indocyanine Green (ICG) in Children

NCT06421103 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-05-20

No results posted yet for this study

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.

Conditions

  • Perfusion
  • Fluorescence Imaging
  • Gastrointestinal Tract Disorders
  • Genitourinary Disease

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.

Sponsors & Collaborators

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Stefano Giuliani · Great Ormond Street Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-30
Primary Completion
2028-08-31
Completion
2028-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06421103 on ClinicalTrials.gov