Not yet recruitingPHASE2INTERVENTIONAL

The Use of 5-ALA in Paediatric Patients With High Grade Brain Tumours

This study is investigating a special dye called 5-ALA, also known as Gliolan, for children aged 3 to 18 who have aggressive brain tumours. The main goal is to find out if this dye is safe for children and if it helps surgeons remove as much of the tumour as possible, while leaving healthy brain tissue untouched. The dye makes tumour cells glow under a special light during surgery, which could help surgeons distinguish between cancerous and normal tissue. By precisely targeting the tumour, the hope is to improve the chances of successful surgery for these young patients. Every child taking part will receive this dye a few hours before their surgery.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

University College, London

Enrolment target

Start

25 Mar 2025

Estimated completion

30 Dec 2026

Brain Tumor

What is this study about?

This study is about helping children aged 3 to 18 who need surgery for an aggressive brain tumour. The main idea is to use a special liquid medicine called 5-ALA (you might hear it called Gliolan) before their operation. This medicine is designed to be taken up by the tumour cells, making them glow a different colour under a special light during surgery. This can help the surgeon see exactly where the tumour is and tell it apart from healthy brain tissue.

The aim is to find out if using 5-ALA is safe for children and if it can help surgeons remove as much of the tumour as possible. When surgeons can clearly see the tumour, it increases the chance of removing more of the harmful cells while protecting the important healthy parts of the brain. This could lead to better outcomes for children undergoing this critical surgery.

Researchers also want to learn if 5-ALA makes it easier to tell the difference between the tumour and normal brain tissue. By collecting this information, they hope to improve future treatments for children with aggressive brain tumours, making surgeries more precise and potentially more effective.

Key takeaways

This study uses a special dye called 5-ALA to help surgeons see brain tumours better in children.
The main goals are to check the dye's safety and see if it helps remove more of the tumour.
Children aged 3-18 with aggressive brain tumours are being considered for the study.
The 5-ALA is given a few hours before surgery, with no extra hospital visits required.
Participation is voluntary, and you can withdraw your child at any time without affecting their care.

Who may be eligible?

To join this study, children must be between 3 and 18 years old. They need to have an MRI scan that suggests they have an aggressive brain tumour, or if they've had a brain tumour like an ependymoma before and it's come back. The doctors must also think that surgery is the best way to treat their tumour.

There are some important health checks to make sure it's safe for a child to take part. This includes having healthy liver and kidney function, normal blood clotting, and healthy blood pressure. Girls who are able to have children will need a negative pregnancy test. Also, a doctor and a team of specialists must agree that removing as much of the tumour as possible is the right step.

Children cannot join if their tumour is known to be slow-growing (not aggressive), or if doctors only plan to take a small sample (biopsy) rather than remove the tumour. They also can't join if they have a rare condition called porphyria, are allergic to 5-ALA or similar medicines, or have a history of being very sensitive to light. Pregnant or breastfeeding women also cannot participate.

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 your child between 3 and 18 years old?
Does your child have an aggressive brain tumour or has one returned?
Do doctors think surgery is the best way to remove the tumour?
Does your child have healthy liver and kidney function, and normal blood clotting?
Does your child have a normal blood pressure?
Is your child not pregnant or breastfeeding (if applicable)?

Answer every question to see your result.

What does participation involve?

If your child takes part, they will receive the 5-ALA medicine by mouth a few hours (between 3 and 6 hours) before their planned brain tumour surgery. This is just a single dose before the operation. During the surgery, the surgeons will use special lights to see if the tumour glows, helping them to guide the removal. Beyond this, the study doesn't involve extra visits or assessments separate from what would normally happen for your child's brain tumour surgery and recovery. The total duration of participation is focused around this single dose and immediate surgical outcome.

Potential risks and benefits

Potential benefits of taking part include the chance that your child's surgeon may be able to remove more of the tumour, potentially leading to a better outcome, because the 5-ALA might make the tumour easier to see. However, there's no guarantee of direct benefit for your child. Potential risks are generally mild and similar to those sometimes seen with other medicines, such as mild stomach upset or sensitivity to light, though these are rare. 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.

Nottingham Children's Hospital
Verified postcode
Nottingham, United Kingdom

Common questions

What is 5-ALA and how does it work?

5-ALA is a special liquid medicine that brain tumour cells absorb. During surgery, when a special blue light is shone on the brain, the tumour cells that have absorbed 5-ALA will glow, making them easier for the surgeon to see and remove.

Will my child have to take any other medicines for this study?

No, your child will only receive the 5-ALA medicine as a single dose by mouth a few hours before their surgery. There are no other study-specific medications.

How long will my child be in the study?

Your child's participation in the study is mainly focused around receiving the 5-ALA dose and their surgery. There are no long-term follow-up visits specifically for the study beyond their normal medical care.

Are there any side effects of 5-ALA?

Most children have no side effects. Rarely, some might feel a bit sick or have some skin sensitivity to light, but steps are taken to protect against this. Your doctor will discuss all potential side effects with you.

Does taking part affect my child's normal treatment?

No, taking part in this study will not change your child's surgery or other planned treatments. It simply adds the use of 5-ALA to their existing care plan to help the surgeon.

How to find out more

Paed 5-ALA Trial Manager

ctc.paed5-ala@ucl.ac.uk 020 7679 9860 Official trial record

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