Active not recruitingOBSERVATIONAL

Contrast-Free Magnetic Resonance Imaging for Breast Disease

Researchers are looking into a new way to scan breasts using an MRI. Currently, to find breast cancer, especially in women with dense breast tissue, an MRI often uses a special dye injected into the body. This study wants to see if a newer MRI technique can identify breast problems, including cancer, without needing this dye. This could make the scan quicker, more comfortable, and avoid the risks associated with the dye. The study is particularly interested in how well this new method works for women who are at a higher risk of breast cancer or have suspected breast issues.

At a glance

Status

Active not recruiting

Sponsor

Perspectum

Enrolment target

1,030

Start

06 Jul 2021

Estimated completion

30 Apr 2027

Breast Cancer Breast Diseases

What is this study about?

When doctors look for breast changes or cancer, they often use a mammogram. For many women, especially those past menopause with less dense breasts, mammograms work very well. However, for women with dense breast tissue – which includes most younger women and many older ones – mammograms can sometimes miss changes because the dense tissue makes it harder to see. This is where other scans like MRI come in.

Traditionally, breast MRI scans often involve injecting a special dye, called a contrast agent, into your body. This dye helps highlight areas of concern. While useful, some people find this injection uncomfortable, and it can add time to the scan. Also, for some people, there are reasons they might not be able to have this dye.

This study is exploring a new way of doing MRI scans for the breast that does not need this dye. Researchers have already used a similar new method to find problems in the liver without contrast. They believe this new MRI technique could help doctors find and understand breast conditions, including cancer, especially in women with dense breasts, without the need for an injection. If successful, this could lead to faster, more comfortable, and safer breast scans in the future.

Key takeaways

This study is testing a new breast MRI scan without dye.
It aims to help detect breast problems, especially in women with dense breasts.
Participation involves an MRI scan for research purposes.
It could lead to more comfortable and accessible breast scans in the future.
Eligibility includes women 30+ referred to a breast clinic.

Who may be eligible?

This study is looking for women aged 30 or older. You would need to have been referred to a specialist breast clinic because of concerns about your breasts or if you're considered to be at a higher risk of breast cancer. Before joining, you'll need to understand what the study involves and be happy to give your permission to take part.

You cannot join the study if you have anything inside your body that makes MRI scans unsafe, such as a pacemaker or certain metal implants. If you have severe claustrophobia (a strong fear of enclosed spaces) which would make an MRI scan very difficult, or if the study doctors think that taking part might be risky for your health in any other way, you would also not be able to participate.

Quick self-check

Am I female and 30 years old or older?
Have I been referred to a specialist breast clinic for a breast concern or risk?
Do I have any metal implants or other items that make MRI unsafe, like a pacemaker?
Am I comfortable with enclosed spaces for an MRI scan?
Am I willing to understand and sign a consent form?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you will have a special kind of MRI scan of your breast. This is an outpatient procedure, meaning you won't need to stay in hospital overnight. The study aims to see how well this new scan works without the need for a contrast injection, so you won't receive the regular contrast dye. The total duration of your participation will involve the time for the MRI scan and any discussions before and after.

Potential risks and benefits

A potential benefit of taking part is contributing to research that could lead to a new, gentler way to detect breast problems, especially for women with dense breasts. This new scan might be quicker and avoid the need for an injection. The main risk is the standard risks associated with an MRI scan, such as feeling uncomfortable in the scanner or claustrophobia, but these scans do not involve radiation. You are free to withdraw from the study at any time without explaining why, and this will not affect your usual medical care.

Locations (1)

Gemini One
Oxford, United Kingdom

Common questions

What is 'dense breast tissue'?

Dense breast tissue means your breasts have more fibrous and glandular tissue compared to fatty tissue. It's very common and normal, but it can make it harder to see changes on a mammogram.

Why is this new MRI different?

The main difference is that it aims to find breast problems without needing a special dye injected into your body, which is usually part of a standard breast MRI.

Will I get my scan results?

The study aims to gather information to develop a new scan. While your doctors will always act on anything concerning found during your care, the primary purpose is research, not individual diagnosis from this specific study scan.

Is an MRI scan safe?

Yes, MRI scans are generally very safe. They use strong magnets and radio waves, not X-rays or radiation. There are certain things, like metal implants, that make them unsafe, which is why screening questions are asked.

What does a 'contrast agent' do?

A contrast agent is a special liquid injected into your bloodstream that helps make certain parts of your body or abnormalities show up more clearly on an MRI scan.