RecruitingOBSERVATIONAL

Predicting Breast Cancer With the BRAVE System

This study is looking into a new system, called BRAVE, to help find breast cancer. Currently, mammograms are the main screening tool, but they can be uncomfortable, use X-rays, and are less effective for women with dense breasts. The BRAVE method uses a special bra to measure stiffness in the breast, as cancerous lumps often feel harder. It doesn't use X-rays or squish the breast, offering a potentially more comfortable and effective option. This research aims to see how good the BRAVE method is at telling the difference between normal breast tissue and various types of breast changes, especially in women with different breast densities. The goal is to develop a kinder, more accurate way to detect breast cancer.

At a glance

Status

Recruiting

Sponsor

Université de Sherbrooke

Enrolment target

300

Start

28 Jan 2025

Estimated completion

31 Dec 2028

Breast Mass Breast Cancer

What is this study about?

Breast cancer is a significant concern for women in the UK, and finding it early is incredibly important. Currently, mammograms (X-rays of the breast) are the main way doctors look for breast cancer. While mammograms are helpful, they do have some drawbacks. They can be uncomfortable because the breast is pressed between two plates, they involve a small amount of X-ray radiation, and they don't work as well for women who have very dense breast tissue.

Because of these limitations, researchers are looking for new and better ways to detect breast cancer. This particular study is evaluating a new method called BRAVE (which stands for "BRA-based Visco-Elastography"). The BRAVE method uses a special bra that can measure how stiff different parts of your breast are. Cancerous lumps often feel harder and stiffer than healthy breast tissue, so this method aims to spot those differences.

The exciting thing about the BRAVE method is that it doesn't use X-rays, and it doesn't involve your breasts being squashed. This could mean a more comfortable and potentially safer way to check for breast cancer in the future. The study is divided into two main parts. The current phase is specifically looking at how well the BRAVE method can tell the difference between different types of breast changes, and how successful it is for women with different breast densities.

Key takeaways

This study is testing a new, gentler way to detect breast cancer without X-rays.
It uses a special bra to measure breast stiffness, not compression.
The BRAVE method could be especially helpful for women with dense breasts.
Participation involves one visit and no known physical risks.
The goal is to find a more comfortable and effective screening tool.

Who may be eligible?

This study is looking for women who are 18 years old or older and are able to understand and sign a consent form in English. You would need to have had a mammogram within the last six months.

Another important requirement is that you must have a breast lump or change that a doctor has recently found, either by feeling it, or through imaging tests like a mammogram, ultrasound, or MRI. Because of this lump or change, your doctor would have referred you for more tests or follow-up imaging.

You cannot take part if you are pregnant or breastfeeding, have breast implants, have had breast surgery or a biopsy before, have any illness that would stop you from completing the examination, or have taken any past or current cancer treatments. The study is specifically for women.

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 newly found breast lump or change?
Have I had a mammogram in the last 6 months?
Am I pregnant or breastfeeding, or do I have breast implants?
Have I had any previous breast surgery or biopsy, or any cancer treatment?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will need to attend one visit, which should last about 75 minutes. During this visit, you'll be asked to wear a special bra that is part of the BRAVE system and complete the examination process. The researchers will also look at information from your medical records. This includes details about your breast density, and the results and dates of any past mammograms or other tests you’ve had related to breast cancer.

Potential risks and benefits

Taking part in this study could help scientists develop a new, more comfortable way to detect breast cancer, which may especially benefit women with dense breasts. There are no known physical risks associated with the BRAVE examination as it does not involve radiation or compression. However, as with any research, there's always a chance you might not personally benefit from taking part. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

CIUSSS de l'Estrie - CHUS
Verified postcode
Sherbrooke, Canada· Recruiting

Common questions

What is the BRAVE method?

The BRAVE method is a new way being tested to find breast cancer. It uses a special bra to measure stiffness in the breast without using X-rays or squashing the breast.

Why is this new method needed?

Current mammograms can be uncomfortable, use X-rays, and don't work as well for women with dense breasts. The BRAVE method aims to be a kinder and more effective option.

Does this study involve radiation?

No, the BRAVE method does not use X-rays or any other radiation. It works by measuring the stiffness of breast tissue.

How long will my visit to the study site take?

If you join the study, you'll need to attend just one visit, which is expected to last about 75 minutes (roughly an hour and a quarter).

Is this method available to everyone now?

No, the BRAVE method is currently being tested in a research study. It is not yet available for general use by the public or doctors.

How to find out more

Amelie Tetu, MSc

amelie.tetu.ciussse-chus@ssss.gouv.qc.ca 819-346-1110 Official trial record

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