Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Clinical safety study on 5-Aminolevulinic acid (5-ALA) in children and adolescents with brain tumors (5-ALA in children and adolescents)

This study is investigating a drug called Gliolan (also known as 5-ALA) which is given to children and teenagers who have certain types of brain tumours. During surgery, this medication makes tumour cells glow under a special light, helping surgeons see them better. The main goal of this study is to find out how safe Gliolan is for children and teenagers and to check for any serious side effects. They also want to understand how well the glowing helps surgeons identify all the tumour tissue, and to learn more about how the body processes 5-ALA. This information will help doctors understand if this treatment is a good option for young patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Universitaet Muenster

Enrolment target

Start

06 Nov 2024

different types of brain tumors

What is this study about?

This study is about a special medicine called Gliolan, which is also known as 5-ALA. It's used by doctors during surgery for certain brain tumours in children and teenagers. The idea is that when children drink this medicine before their operation, it makes the tumour cells glow pink under a special blue light during surgery. This can help surgeons see the tumour more clearly, making it easier to remove as much of it as possible without damaging healthy brain tissue.

The main thing doctors want to learn from this study is about safety. They are carefully watching for any serious side effects that might happen during or after surgery in children and teenagers who receive 5-ALA. This information is really important because it helps them understand if this treatment is safe to use in younger patients.

Beyond safety, the study also aims to figure out how well this glowing effect actually works. They will compare what glows during surgery with what they see under a microscope afterwards to see if the glowing accurately shows all the tumour tissue. They also want to understand more about how children's bodies handle the 5-ALA medicine. All this information will help doctors decide if 5-ALA is a good and safe tool to improve surgery for young people with brain tumours.

Key takeaways

This study is looking at a drug called Gliolan (5-ALA) for children and teenagers with brain tumours.
The drug helps surgeons see tumour tissue during an operation by making it glow.
The main aim is to check how safe Gliolan is in this age group.
Doctors also want to know how well the glowing helps identify the tumour.
Participation involves drinking the medicine before surgery and close monitoring afterwards.

Who may be eligible?

This study is open to both boys and girls of any age who have been diagnosed with certain types of brain tumours. Specifically, it's for those with a single brain tumour that shows up clearly on a scan (doctors call this 'contrast-enhancing') and is located within the brain tissue.

Your doctor will be able to tell you if the specific kind of brain tumour you have and its location make you a good fit for this study. They will also consider other aspects of your health to make sure that taking part is safe for you.

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.

Do you have a brain tumour?
Does your tumour show up clearly on scans?
Is your tumour located within the brain tissue?
Are you or your child a boy or a girl?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be given the Gliolan medicine (5-ALA) as a drink before your scheduled brain tumour surgery. During the surgery, the doctors will use special lights to help them see if the tumour glows, which is meant to help them remove it. After your surgery, the medical team will closely monitor you for any side effects. You will also have standard follow-up appointments, including scans like an MRI, to see how much of the tumour was removed. If you agree, doctors might also take a few small blood samples after you've had the 5-ALA to understand how your body processes it. The total duration of your participation will depend on your hospital visits and follow-up plans.

Potential risks and benefits

Taking part in any medical study has potential benefits and potential risks. A potential benefit of this study is that the 5-ALA might help your surgeon see the tumour more clearly during the operation, possibly leading to a more complete removal. However, it's important to know that this is not guaranteed, and the main goal of this study is to evaluate safety. Potential risks include side effects from the Gliolan medicine or complications related to brain surgery, though these will be closely monitored. You will be told about all known risks before you decide to join. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (2)

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

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Unverified
Germany
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Unverified
Netherlands

Common questions

What is 5-ALA or Gliolan?

It's a special drinkable medicine that can make certain brain tumour cells glow during surgery, helping doctors see them better.

Why is this study being done?

Doctors want to make sure 5-ALA is safe for children and teenagers with brain tumours and to see how well it helps during surgery.

Will I definitely get my tumour removed completely if I take part?

The hope is that it helps, but there's no guarantee. The main aim is to learn about its safety and effectiveness.

Will I have any extra tests if I join?

You'll have your usual surgery and follow-up scans, but you might also have a few extra blood tests if you agree.

Can I change my mind about joining the study?

Yes, you can decide to leave the study at any time, and it won't affect your medical care.