NCT06421103

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
27mo left

Started Jun 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Jun 2024Aug 2028

First Submitted

Initial submission to the registry

January 8, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 20, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

May 20, 2024

Status Verified

May 1, 2024

Enrollment Period

4.2 years

First QC Date

January 8, 2024

Last Update Submit

May 15, 2024

Conditions

PerfusionFluorescence ImagingGastrointestinal Tract DisordersGenitourinary Disease

Keywords

Paediatric SurgeryPediatric SurgeryFluorescenceImagingFluorescence Guided Surgery (FGS)Intra-operative perfusion assessmentIndocyanine Green

Outcome Measures

Primary Outcomes (2)

  • Minimum clinically useful dose of ICG in children

    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.

    60 minutes (intra-operative)

  • Number of adverse drug events at each dose level

    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

    30 days

Secondary Outcomes (3)

  • Surgical complications

    30 days

  • Post-operative morbidity

    90 days

  • Length of stay

    90 days

Study Arms (1)

Micro-dosing Indocyanine Green (ICG)

EXPERIMENTAL

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.

Drug: Indocyanine Green (ICG)

Interventions

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.

Also known as: Verdye by DiagnosticGreen
Micro-dosing Indocyanine Green (ICG)

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children aged ≤18 years of age
  • Elective surgery including gastrointestinal or genitourinary tract perfusion assessment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Great Ormond Street Hospital for Children

London, WC1N 3JH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Digestive System DiseasesUrogenital Diseases

Interventions

Indocyanine Green

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Stefano Giuliani

    Great Ormond Street Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Giuliani

CONTACT

02074059200stefano.giuliani@gosh.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Dose escalation with backfilling.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2024

First Posted

May 20, 2024

Study Start

June 1, 2024

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

May 20, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)