AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

FIDES: Focused Ultrasound-mediated Blood-Brain Barrier Opening In Pontine Diffuse Midline Glioma (DMG) to Enhance Systemic Therapy with Temozolomide – an exploratory pilot and feasibility trial

This study, called FIDES, is exploring a new approach for treating Diffuse Midline Glioma (DMG), a serious type of brain tumour. We're investigating if using focused ultrasound can temporarily open the brain's protective barrier, allowing more of a standard chemotherapy drug, Temozolomide, to reach the tumour. This is an early-stage study, meaning it's a pilot and feasibility trial. We want to see how safe this new method is and if it makes the chemotherapy more effective. We'll be closely monitoring for any side effects and observing how well patients respond to the treatment over six months, looking at things like tumour growth and overall health. The aim is to find better ways to fight DMG.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Universitair Medisch Centrum Utrecht

Enrolment target

Start

23 Mar 2026

Diffuse Midline Glioma, H3K27-altered

What is this study about?

This study is called FIDES, and it's looking into new ways to treat a specific type of brain tumour called Diffuse Midline Glioma, specifically those with a genetic change known as H3K27-altered. This type of tumour can be very challenging to treat because the brain has a natural protective shield, called the blood-brain barrier. This barrier is very good at keeping harmful substances out, but it can also stop important medicines from reaching the tumour effectively.

FIDES is exploring a new technique that uses focused ultrasound. Think of ultrasound as sound waves, similar to those used in scans during pregnancy. In this study, these sound waves are carefully directed towards the tumour. The idea is that these sound waves can gently and temporarily open up tiny gaps in the blood-brain barrier in the area of the tumour. This temporary opening would allow more of a standard chemotherapy drug, called Temozolomide, to get into the brain and reach the tumour cells, hopefully making the treatment more powerful.

This is an early-stage study, sometimes called a 'pilot and feasibility' trial. This means we're carefully checking a few important things first. We want to see if using focused ultrasound in this way is safe for patients, and whether we can successfully open the blood-brain barrier. We'll also be closely watching to see how patients respond to this combined treatment and if it helps to slow down or stop the tumour from growing. The information we gather will help us decide if this approach is promising enough for larger studies in the future, with the ultimate goal of improving treatment for Diffuse Midline Glioma.

Key takeaways

This study is for a specific brain tumour called Diffuse Midline Glioma (DMG).
It tests a new way to help chemotherapy medicine reach the tumour better.
This method uses sound waves (focused ultrasound) to temporarily open the brain's protective barrier.
It's an early-stage study focusing on safety and how well the treatment works.
Participants must be 18 or older and have the specific type of DMG being studied.
Taking part means regular check-ups and brain scans to monitor treatment.

Who may be eligible?

To be considered for this study, you would need to be at least 18 years old. There's no upper age limit for taking part. Both men and women are welcome to participate.

As this study focuses on a very specific type of brain tumour, you would need to have a diagnosis of Diffuse Midline Glioma that has a particular genetic marker called H3K27-altered. The study team would be able to check if your tumour fits this description.

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.

Am I 18 years old or older?
Do I have a diagnosis of Diffuse Midline Glioma (DMG)?
Has my tumour been identified as 'H3K27-altered'?
Am I open to receiving a standard chemotherapy drug (Temozolomide)?
Am I able to undergo MRI scans and ultrasound procedures?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive the chemotherapy medicine Temozolomide, which comes in capsule form. You would also undergo a procedure involving focused ultrasound to help open the blood-brain barrier. This treatment process would involve multiple sessions. The study team will closely monitor your health and how the treatment is working through regular hospital visits, including physical examinations, blood tests, and MRI scans of your brain. These scans will help us see if the blood-brain barrier is opening as intended and how the tumour is responding. The entire duration of your participation in the study, including treatment and follow-up, would be carefully explained by the research team.

Potential risks and benefits

Potential benefits of taking part in this study include the possibility that this new combined treatment might work better than standard care by allowing more chemotherapy to reach the tumour. You would also be contributing to important research that could help others with Diffuse Midline Glioma in the future. However, as with any medical treatment, there are potential risks. These could include side effects from the chemotherapy or from the focused ultrasound procedure. The research team will explain all known risks in detail. It's important to remember that participating in a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (1)

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

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Unverified
Netherlands

Common questions

What is Diffuse Midline Glioma (DMG)?

DMG is a serious type of brain tumour that grows in the middle part of the brain or spinal cord.

What is the blood-brain barrier?

It's a natural protective layer in your brain that helps keep harmful substances out, but it can also stop medicines from getting to a tumour.

How does focused ultrasound help?

It uses sound waves to temporarily create tiny openings in the blood-brain barrier, hoping to let more medicine reach the tumour.

What is Temozolomide?

It's a common chemotherapy drug used to treat brain tumours.

Is this a new treatment?

The idea of using focused ultrasound with Temozolomide for DMG is being explored in this early-stage study to see if it's safe and effective.