PerfusionNCT06421103
Micro-dosing Indocyanine Green (ICG) in Children
A study testing Indocyanine Green (ICG) in people with Perfusion and Fluorescence Imaging, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Perfusion, Fluorescence Imaging, Gastrointestinal Tract Disorders
- What is being tested?
- Indocyanine Green (ICG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2024to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged ≤18 years of age
- Elective surgery including gastrointestinal or genitourinary tract perfusion assessment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Great Ormond Street Hospital for Children
London, WC1N 3JH
Stefano Giuliani, 02074059200 ext. 0669, stefano.giuliani@gosh.nhs.uk
About this study
Official title: Investigating Micro-dosing of Indocyanine Green (ICG) for Intraoperative Perfusion Assessment 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.
Read the detailed description
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
- Being tested
- Indocyanine Green (ICG)
- Keywords
- Paediatric Surgery, Pediatric Surgery, Fluorescence, Imaging, Fluorescence Guided Surgery (FGS), Intra-operative perfusion assessment, Indocyanine Green
- Medical subject headings
- Digestive System Diseases, Urogenital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine Green (ICG)Drug
Also called Verdye by DiagnosticGreen
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Indocyanine Green (ICG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 30 days
Secondary outcomes (3)
Surgical complications
Intra-operative and early postoperative complications and mortality (defined as an event observed within 30 days after surgery). Frequency and details.
Measured: 30 days
Post-operative morbidity
Further procedures, complications and mortality occuring within the 30 - 90 day time period (late post-operative complications). Frequency and details.
Measured: 90 days
Length of stay
Time in hospital post-procedure
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study startJun 2024 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerfusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dose escalation with backfilling.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Giuliani, Principal investigator, Great Ormond Street Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421103
- Sponsor's protocol ID
- 23BO01
- Status last verified
- May 2024
- First submitted
- 8 Jan 2024
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Micro-dosing of Indocyanine Green (ICG) for Intraoperative Perfusion Assessment in Children.
- ClinicalTrials.gov ID
- NCT06421103
- Acronym / sponsor ID
- 23BO01
- Keywords
- Paediatric Surgery, Pediatric Surgery, Fluorescence, Imaging, Fluorescence Guided Surgery (FGS), Intra-operative perfusion assessment, Indocyanine Green
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose escalation with backfilling.
| Arm | Type | Receives |
|---|---|---|
| Micro-dosing Indocyanine Green (ICG) | Experimental | Drug: 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children aged ≤18 years of age
- Elective surgery including gastrointestinal or genitourinary tract perfusion assessment
Key exclusion criteria (8 listed)
- Renal and liver dysfunction
- Active infection
- Coagulopathy
- Complex congenital heart defect
- Previous documented allergy to ICG injection or other iodinated contrast agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indocyanine Green (ICG)Also: Verdye by DiagnosticGreenCohorts 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. | Drug | Micro-dosing Indocyanine Green (ICG) |
Primary outcome
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.
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
3 secondary outcomes
Surgical complications
Time frame: 30 days
Post-operative morbidity
Time frame: 90 days
Length of stay
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Individual participant dataSharing planned: No
Related trials for Perfusion
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefano Giuliani principal investigator
Great Ormond Street Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indocyanine Green (ICG) in people with Perfusion and Fluorescence Imaging, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefano Giuliani (02074059200 ext. 0669, stefano.giuliani@gosh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum clinically useful dose of ICG in children (time frame: 60 minutes (intra-operative)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.