RecruitingPhase IInterventional

Sonodynamic therapy using focused ultrasound in glioblastomas

This early-stage study (Phase 1) is exploring a new treatment called sonodynamic therapy (SDT) for glioblastoma, a serious type of brain tumour. SDT involves giving a special medicine called 5-ALA that collects in the tumour. Then, focused ultrasound waves are used to activate this medicine, aiming to destroy the tumour cells without harming healthy brain tissue. This trial is looking at how safe and practical this approach is. Researchers hope this could one day be a less invasive alternative to current treatments. The study is for people aged 18-70 with a suspected glioblastoma.

At a glance

Status

Recruiting

Phase

Phase I

Sponsor

Imperial College Healthcare NHS Trust

Enrolment target

Start

01 Feb 2026

Estimated completion

01 Nov 2026

Gliobastoma

What is this study about?

Glioblastoma is a very challenging brain tumour to treat. Current treatments often involve surgery and radiotherapy, but even with these, it's hard to completely remove the tumour and stop it from growing back. Scientists are always looking for new, gentler ways to tackle this cancer, especially methods that don't involve invasive surgery on the brain.

This study is investigating a new approach called Sonodynamic Therapy (SDT). Think of it like a two-part process. First, participants are given a special medicine called 5-ALA. This medicine is safe on its own, but it has a clever trick: it's designed to be absorbed much more by the tumour cells than by healthy brain cells. Once the medicine has built up in the tumour, focused ultrasound waves are used. These sound waves are also harmless on their own. However, when the sound waves meet the collected 5-ALA within the tumour, they activate the medicine, which then starts to destroy the cancer cells. The beauty of this method is that the ultrasound can be aimed very precisely through the skull, targeting only the tumour without needing to cut into the brain.

The main goal of this particular study is to see if this new SDT treatment is safe for people with glioblastoma and if it's practical to carry out. Because it's an early-stage (Phase 1) trial, the focus is on safety first and understanding how the treatment works in humans. If successful, this research could pave the way for a new, less invasive and more targeted way to treat glioblastoma in the future.

Key takeaways

This is a Phase 1 study for glioblastoma, focusing on safety and feasibility.
The treatment uses a medicine activated by focused sound waves.
The aim is to find a less invasive way to treat brain tumours.
You will receive the new treatment a week before your scheduled tumour surgery.
Participation involves several MRI scans and an overnight hospital stay.
The study has potential risks, but severe side effects have been rare in previous experiences.

Who may be eligible?

This study is designed for adults aged between 18 and 70 years old who have a suspected glioblastoma brain tumour. The tumour needs to be in a specific part of the brain that could be removed with surgery, and it should be between 1 and 5 centimetres wide. You also need to be generally well enough to take part in the study activities.

There are several reasons why someone might not be able to join. For example, if your tumour is causing significant swelling or pushing your brain out of place, or if you've recently had bleeding in your brain. You also can't have certain metal objects in your head, like clips or shunts, or serious heart problems. If you're on blood-thinning medication or have a bleeding disorder, that would also prevent you from participating. Anyone who has problems with MRI scans, like severe claustrophobia or non-MRI-compatible implants, would also be unable to join.

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.

Are you between 18 and 70 years old?
Do you have a suspected glioblastoma tumour?
Is your tumour between 1 and 5 cm in size and in a treatable location?
Are you able to undergo MRI scans?
Do you have any metal implants in your head, like clips or shunts?
Do you have serious heart problems or a bleeding disorder?

Answer every question to see your result.

What does participation involve?

If you join this study, you would have the Sonodynamic Therapy (SDT) one week before your planned surgery. Three hours before the SDT, you'll take a dose of the special medicine called 5-ALA orally. For the procedure, your head will be gently shaved, and a special frame will be fitted to keep your head still during the treatment. You'll then have several MRI scans to help the doctors precisely target the tumour.

The treatment itself involves sound waves being delivered over about 20 minutes for each targeted area. Because several areas might need treatment, the whole process could take up to 2-3 hours. During this time, the medical team will be checking on you regularly and asking how you feel, so they can adjust the treatment if needed. Afterwards, you'll have another MRI scan and stay in the hospital overnight. The next day, after another MRI, you'll likely be discharged if you're stable.

Before your surgery, about a week after the SDT, you'll have a follow-up appointment which includes a check-up and another MRI scan. The study team will be in close contact throughout this period to monitor your progress and well-being.

Potential risks and benefits

There are no direct benefits to you from taking part, but the information gained from this study could help future patients with glioblastoma. This is a very early-stage trial, so the main focus is on safety, and there are potential risks. The procedure itself, using the focused ultrasound and MRI, carries risks such as discomfort, dizziness, or temporary neurological changes like numbness. There are also risks linked to the contrast dye used in MRI and the 5-ALA medicine, which can cause side effects like headaches or changes in blood tests. While serious problems like brain swelling, bleeding, or permanent neurological damage are unlikely and closely monitored, they are possible. The medical team has built-in safety measures, such as continuous monitoring and the ability to stop the treatment immediately. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

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

Imperial College Healthcare NHS Trust
City only
London, England

Common questions

What is glioblastoma?

Glioblastoma is a very serious and fast-growing type of brain tumour.

What is Sonodynamic Therapy (SDT)?

It's a new treatment that uses a special medicine activated by focused sound waves to target and destroy tumour cells.

Is this a new treatment?

Yes, this is an early-stage study (Phase 1), which means it's one of the first times this specific treatment is being tested in humans.

Will I have to have surgery if I join this study?

Yes, the SDT treatment is given about a week before your planned brain surgery for the tumour.

How long will I be in the hospital for the treatment?

You will be in the hospital overnight after the SDT treatment for monitoring, and if you are stable, you will be discharged the next day.

How to find out more

Wladyslaw Gedroyc

w.gedroyc@imperial.ac.uk +44 (0)20331 10327 Official trial record

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