RecruitingPHASE1INTERVENTIONAL

MRI-Guided Ultrasound Stimulated Microbubbles Radiation Treatment for Patients with Chest-Wall and Locally Advanced Breast Cancer

This study is investigating a new treatment for breast cancer that combines special ultrasound, tiny bubbles, and standard radiation therapy. It's for patients with breast cancer affecting the chest wall or those with more advanced breast cancer. The aim is to see if using MRI-guided ultrasound with microbubbles can boost the effects of radiation treatment. Participants will lie on an MRI table, where ultrasound targets the tumour. Following this, they will receive their usual radiation treatment. This is an early-stage study (Phase 1) focused on checking if this new method is possible and safe, rather than how well it works compared to other treatments.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Sunnybrook Health Sciences Centre

Enrolment target

Start

01 Jul 2024

Estimated completion

01 Mar 2029

Breast Cancer

What is this study about?

This study is looking into a new way to treat breast cancer, specifically for those with breast cancer that has spread to the chest wall or is considered advanced (known as "locally advanced breast cancer"). The main idea is to combine two technologies: special MRI-guided ultrasound and very tiny bubbles called microbubbles, with the standard radiation treatment you might already be having.

Think of it like this: the MRI helps doctors see the tumour very clearly. Then, a focused ultrasound machine directs sound waves precisely to the cancer area. At the same time, tiny bubbles are given, which are stimulated by the ultrasound. The hope is that these bubbles can make the cancer cells more sensitive to the radiation treatment that you'll receive shortly after the ultrasound. By making the radiation more effective, doctors hope to get better results in treating the cancer.

This is an early-stage study, called a Phase 1 trial. In this phase, researchers are mainly checking if this new combined treatment is safe and practical to use in people. They are not primarily testing how well it cures cancer yet, but rather making sure the method works and is well-tolerated. It's an important step in developing new potential treatments for breast cancer.

Key takeaways

Exploring a new way to boost standard breast cancer radiation.
Uses special MRI-guided ultrasound and tiny bubbles.
Specifically for chest-wall and locally advanced breast cancer.
It's a Phase 1 study, focusing on safety and feasibility.
Does not replace your planned radiation treatment, but adds to it.

Who may be eligible?

To join this study, you would generally need to be at least 18 years old and have a confirmed diagnosis of breast cancer, including different types like invasive ductal or lobular carcinoma. Your cancer should be either early-stage, locally advanced (Stage IIA to IIIC), or even Stage IV. A team of cancer specialists will need to agree that radiation treatment is a suitable option for you.

You also need to be able to understand the study and provide your agreement to take part. There are some practical requirements too, such as weighing less than 140kg, having the tumour easily accessible for the ultrasound, and being able to tell the medical team how you're feeling during the procedure.

However, you couldn't join if you are pregnant or breastfeeding, or if you can't have a contrast-enhanced MRI scan. Other reasons to be excluded include certain metallic or breast implants, severe heart, brain, kidney, or blood conditions, or if the tumour area has open sores or bleeding.

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 18 years old or over?
Do you have a biopsy-confirmed breast cancer diagnosis?
Are you suitable for radiation treatment, as decided by your cancer team?
Are you able to have an MRI scan with contrast?
Do you *not* have certain metallic or breast implants?
Are you *not* pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first have a detailed check-up to make sure the study is right for you. The main part of the treatment involves lying on an MRI table that has a special ultrasound device built into it. Your tumour will be carefully positioned close to this device. While you are there, the focused ultrasound will be used on the tumour. During this time, you'll receive an injection of the 'microbubbles' (called Definity Suspension for Injection).

After this specific ultrasound part, you will receive your standard radiation treatment using a LINAC machine, just as your doctors would normally plan for you. The study will monitor how you respond to this combined treatment and keep an eye on any side effects. The exact number of visits and the total duration of your participation will depend on your individual radiation treatment plan, as the ultrasound procedure is combined with your scheduled radiation sessions.

Potential risks and benefits

Participating in this study might offer the potential benefit of a new approach to make your radiation treatment more effective against your breast cancer. However, as this is an early-stage study, the primary goal is to understand if the treatment is safe and practical, not necessarily to provide direct benefits. As with any medical procedure, there are potential risks, which will be fully explained to you before you agree to take part. These could include side effects from the ultrasound, the microbubbles, the MRI, or the radiation. 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· Recruiting

Common questions

What are microbubbles?

Microbubbles are tiny gas bubbles, smaller than a red blood cell. They're often used to improve images in scans, but in this study, we hope they might help radiation work better.

What does a 'LINAC' do?

A LINAC (Linear Accelerator) is the standard machine used in hospitals to deliver radiation therapy for cancer treatment.

Is this a new type of radiation therapy?

No, you'll receive your usual radiation therapy. This study is testing if using ultrasound and microbubbles alongside it can make the *existing* radiation treatment more effective.

Will I feel anything during the ultrasound?

You'll be asked to communicate any sensations you feel during the ultrasound part of the procedure so the medical team can adjust as needed. Doctors will make you as comfortable as possible.

What if I change my mind about participating?

You can leave the study at any time without having to give a reason. This won't affect your ongoing medical care.

How to find out more

Gregory Czarnota, MD, Ph D.

gregoyczarnota@sunnybrook.ca +1 (416) 4806128 Official trial record

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