Active not recruitingNAINTERVENTIONAL

Blood-Brain Barrier Disruption Using Transcranial MRI-Guided Focused Ultrasound

This research is investigating a novel approach for treating brain tumours. It uses focused ultrasound waves, guided by an MRI scan, to temporarily open the blood-brain barrier – a natural protective shield around the brain. The idea is that by opening this barrier, a cancer drug called doxorubicin might be able to get into the brain tumour and surrounding areas more effectively. This initial study is specifically focused on understanding if this method is safe for people with brain tumours. If safety is confirmed, future studies will then look at how well this treatment works to help patients. We are recruiting adults aged 18 to 70 for this important first step.

At a glance

Status

Active not recruiting

Phase

Sponsor

InSightec

Enrolment target

Start

01 Oct 2014

Estimated completion

01 Dec 2026

Brain Tumor

What is this study about?

Imagine your brain has a very clever security system called the blood-brain barrier. It's like a protective shield that only lets certain things pass from your blood into your brain, keeping out harmful substances. While this is great for protection, it can also stop important medicines, like those used to treat brain tumours, from reaching where they need to go.

This study is exploring a new technique that uses special sound waves, called focused ultrasound, to gently and temporarily open this protective barrier. It's guided by an MRI scan, which is like a detailed internal map of your brain, to make sure the sound waves are directed precisely to the area around the brain tumour. The aim is to see if, by carefully opening this barrier, we can help a chemotherapy drug called doxorubicin get into the tumour more easily.

The main goal of this particular study is to check if this method is safe. This is always the first step for any new treatment. If we find that it's safe, then later studies can investigate how well it works to treat brain tumours. This research could potentially pave the way for more effective brain tumour treatments in the future.

Key takeaways

This study is testing a new way to deliver medicine to brain tumours.
It uses special sound waves (ultrasound) to temporarily open the brain's protective barrier.
The main goal is to check if this method is safe.
Participation involves MRI scans, the ultrasound procedure, and follow-up visits.
You would be helping to develop future treatments for brain tumours.

Who may be eligible?

This study is looking for men and women between the ages of 18 and 70. You will need to be well enough to understand and agree to take part, and have a brain tumour where the targeted area is less than 2.5 cm across. It's important that you can communicate clearly during the procedure and are expected to live for at least three more months to attend all visits. If you've had brain surgery recently, you'll need to have waited at least 14 days since then.

There are some reasons why you might not be able to join. For example, if you have certain types of scars or skin conditions on your scalp where the ultrasound would be applied, or if you have metal clips implanted in your skull (though shunts are usually okay). You also can't have symptoms of increased pressure in your head, such as severe headaches or sickness.

We also need to make sure you don't have certain heart conditions, severe high blood pressure, or a history of bleeding problems. If you're taking blood-thinning medicines like aspirin or NSAIDs, or if you have conditions like diabetes treated with insulin, you might not be able to take part. Your medical team will carefully check all these details to see if this study is right 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.

Are you between 18 and 70 years old?
Is the targeted part of your brain tumour less than 2.5 cm wide?
Can you understand and agree to take part in the study?
Are you able to attend all planned hospital visits and communicate during the procedure?
Do you have certain heart or bleeding conditions that might make you unsuitable?
Have you recently had brain surgery (within the last 14 days)?

Answer every question to see your result.

What does participation involve?

If you join this study, the main part of the treatment involves using focused ultrasound while you are in an MRI scanner. Before this, you'll have some check-ups and scans. During the ultrasound procedure, a small amount of a special dye will be given into your arm, as well as the cancer drug doxorubicin. You'll need to be able to talk to the team during the ultrasound process itself.

After the treatment, you'll have several follow-up visits and scans to monitor your health and how you're responding. These visits will check for any side effects and see how the tumour is behaving. The total duration of your participation in the study, including all the follow-up checks, is expected to be at least three months. You won't be given any new medications specifically as part of the study (other than the doxorubicin and ultrasound contrast agent), but your existing medications will be reviewed.

Potential risks and benefits

As this is a safety study, the potential direct benefit to you from this new treatment is not yet known. However, by taking part, you would be contributing vital information that could help others with brain tumours in the future. Potential risks could include side effects from the focused ultrasound or the medications used, although the study aims to carefully monitor for these. There's also a chance the blood-brain barrier opening might not work as intended. It's crucial to remember that your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Sunnybrook Health Sciences Centre
Verified postcode
Toronto, Canada

Common questions

What is the blood-brain barrier?

It's a natural protective shield around your brain that prevents many substances, including some medicines, from entering.

How does focused ultrasound help?

It uses targeted sound waves, guided by an MRI, to temporarily open this barrier, potentially allowing medicines to reach brain tumours more effectively.

Is this treatment painful?

While you're in the MRI scanner, you'll be asked to communicate any sensations you feel. The team will ensure your comfort throughout. The procedure itself is not expected to be painful.

What is doxorubicin?

Doxorubicin is a chemotherapy drug commonly used to treat various types of cancer. This study is exploring if it can better reach brain tumours with the help of the ultrasound.

How long will I be in the study?

You'll be followed for at least three months to check on your health and the effects of the treatment. This includes the procedure day and follow-up visits.