RecruitingNAINTERVENTIONAL

Micro-dosing Indocyanine Green (ICG) in Children

This study focuses on finding the best and safest amount of a special dye, Indocyanine Green (ICG), for children having surgery on their tummy (gastrointestinal tract) or urinary system (genitourinary tract). During these operations, doctors use ICG to see how well blood is flowing to organs. This helps them make sure the organs are healthy and get enough blood, which can lead to better results from surgery. While ICG is already used safely in children, doctors aren't sure what the smallest effective dose is. This study aims to find that minimal dose, check that it's safe, and see exactly how it works during surgery for children aged up to 18 years old.

At a glance

Status

Recruiting

Phase

Sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

Enrolment target

Start

01 Jun 2024

Estimated completion

01 Aug 2028

Perfusion Fluorescence Imaging Gastrointestinal Tract Disorders Genitourinary Disease

What is this study about?

Imagine doctors are doing an operation on a child's tummy or urinary system. It's really important for them to see if the organs are getting enough healthy blood flow. This study is testing a special green dye called Indocyanine Green, or ICG for short, which helps doctors do just that.

When ICG is given to a patient, it travels through their blood. During surgery, doctors can shine a special light on the organs, and the ICG lights up, showing them exactly where the blood is flowing and how well. This can help surgeons make better decisions during the operation, potentially leading to better outcomes for the child. While this dye is already used in children and is considered safe, doctors don't yet know the smallest amount of ICG that works best. They want to avoid giving more medicine than needed.

So, this study is designed to find that 'sweet spot' – the lowest possible dose of ICG that still gives doctors a clear picture of blood flow during these important operations. They will also be carefully checking how safe this dye is for children and how it looks on their special imaging equipment. The goal is to make these surgeries even safer and more effective for children. This study will include children from birth up to 18 years of age.

Key takeaways

This study is about safe dye use in children's surgery.
It aims to find the lowest effective dose of ICG for blood flow checks.
It covers children up to 18 having planned tummy or urinary operations.
The goal is to improve surgical safety and outcomes for children.
Participation involves receiving the dye during already planned surgery.

Who may be eligible?

This study is open to children aged 18 years or younger. To be considered, a child must be scheduled for a planned operation that involves checking blood flow to their tummy or urinary organs. This type of surgery is known as elective surgery, meaning it's planned in advance rather than an emergency.

However, there are certain situations where a child would unfortunately not be able to join the study. This includes if they have problems with their kidneys or liver, or if they have an active infection, or issues with their blood clotting. Children with certain complex heart conditions, or a known allergy to ICG or similar dyes, would also not be able to take part.

Other reasons for not being able to join include if they have a condition called hyperthyroidism, if they are a very premature baby or a newborn baby who might need a special blood exchange, or if they are currently taking certain types of heparin (a blood thinner) that contain sodium bisulphite.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is my child 18 years old or younger?
Is my child having planned surgery on their tummy or urinary system?
Does my child have healthy kidneys and liver?
Does my child have any known allergies to the ICG dye or similar medicines?
Is my child free from active infections or complex heart problems?

Answer every question to see your result.

What does participation involve?

If a child joins this study, they will receive a small dose of the Indocyanine Green (ICG) dye during their planned surgery. The study doesn't involve any extra visits or changes to the surgical plan other than receiving this dye. Doctors will use special equipment during the operation to observe how the dye helps them see blood flow. There won't be any new medication to take outside of the surgery itself, nor any additional follow-up appointments specifically for the study. The total duration of participation is limited to the time spent in surgery when the dye is administered and observed.

Potential risks and benefits

We hope that finding the lowest effective dose of ICG will make surgery safer and more effective for children in the future, by helping doctors understand blood flow better. As with any medical procedure, there are some potential risks with ICG, such as allergic reactions, and these will be carefully monitored. The study specifically aims to confirm the safety of ICG in children at different doses. Please remember that taking part is entirely voluntary, and you have the right to withdraw your child from the study at any time, for any reason, without it affecting their medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Great Ormond Street Hospital for Children
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is ICG?

ICG (Indocyanine Green) is a special green dye that doctors use during surgery to see how well blood is flowing to organs in the body.

Why is this study important?

This study is important because it aims to find the smallest, safest amount of ICG needed for children during surgery, making sure they get the best possible care with minimal medicine.

Will my child have extra tests for this study?

No, your child will not have any extra tests or visits specifically for this study. The dye will be given during their already planned surgery.

Is ICG safe for children?

ICG is generally considered safe for use in children, and this study will carefully check its safety profile while looking for the lowest effective dose.

What kind of operations are included?

This study includes planned operations on a child's tummy (gastrointestinal tract) or urinary system (genitourinary tract) where doctors need to check blood flow.

How to find out more

Stefano Giuliani

stefano.giuliani@gosh.nhs.uk 02074059200 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.