CompletedObservational

Acceptability of radiofrequency assessment of breast density

Breast cancer is a big concern for women in the UK, especially those aged 35 to 49. Doctors believe that identifying younger women at higher risk, for example due to breast density, could lead to earlier screening and better outcomes. Currently, this often involves extra hospital visits, which can be difficult for busy women. This study is testing a new, easy-to-use device called Mi~Scan®. It checks breast density quickly and painlessly, without needing an X-ray. The research aims to find out if women and healthcare professionals find this new method acceptable and helpful. By taking part, women will help improve early detection methods, potentially benefiting many others in the future.

At a glance

Status

Completed

Sponsor

University of Manchester

Enrolment target

240

Start

01 May 2025

Estimated completion

28 Feb 2026

Early detection of breast cancer risk in younger women

What is this study about?

Breast cancer is a serious illness, affecting many women in the UK. For women aged 35 to 49, it's sadly the most common cause of death. Doctors are always looking for ways to spot who might be at higher risk of getting breast cancer earlier. If a woman's risk is known sooner, she could be offered earlier tests and advice, which could save her life.

One important factor linked to breast cancer risk is 'breast density'. This describes how much dense tissue is in the breast. The more dense tissue, the higher the risk. Currently, breast density is usually measured using special X-rays called mammograms. While these are very important, they often mean extra appointments at a specialist clinic. This can be tricky for younger women who are often working, looking after children, or have other responsibilities.

That's why this study is so important. A company called Micrima Ltd. has created a new, simple device called Mi~Scan®. It's a quick, painless desk-top machine that can check breast density without needing a mammogram. This study wants to find out if women and the healthcare staff using it find this new Mi~Scan® device easy to use and acceptable. By doing this research, we hope to make it easier for more women to get their breast density checked, potentially leading to earlier risk assessments and better protection against breast cancer.

Key takeaways

This study evaluates a new, painless way to check breast density.
It aims to identify younger women (30-49) potentially at higher breast cancer risk.
The new Mi~Scan® device could make early risk assessment easier and quicker.
You'll contribute to research that could improve future breast cancer screening.
Participation involves a scan, a questionnaire, and potentially a discussion group.
Shopping vouchers are provided to thank you for your time.

Who may be eligible?

This study is looking for women who were born biologically female, are between 30 and 49 years old, and are able to understand what the study involves and agree to take part. If you're joining through your local GP surgery, you'll need to be registered there.

However, there are some reasons why you wouldn't be able to join. For example, if you've already had breast cancer, or if you've had surgery to remove both breasts (a double mastectomy). You also can't take part if you're pregnant, breastfeeding, or already have a known high risk of breast cancer due to your family history or specific gene changes.

Also, if you have certain medical devices like a heart pacemaker, breast implants, visible areas of broken skin on your breast or armpit, or some types of permanent tattoos, you won't be able to participate. Essentially, the aim is to ensure the study is safe for you and that the device can provide accurate results.

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.

I was born biologically female.
I am between 30 and 49 years old.
I can understand the study details and agree to take part.
I have not had breast cancer or a double mastectomy.
I am not pregnant or breastfeeding.
I do not have breast implants or certain electronic devices in my body.

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be one of 240 women asked to have the Mi~Scan® breast density check. This is a quick and painless procedure. After the scan, you'll complete a short questionnaire. Around half of the participants will attend at their local GP surgery, and the other half at community locations.

Some women (up to 24) will also be invited to take part in a focus group, which is a discussion with other women about their experiences. To thank you for your time, you'll receive shopping vouchers as a reimbursement. The study is expected to run from November 2024 to November 2025.

Potential risks and benefits

By taking part in this study, you could help improve how we identify women at higher risk of breast cancer much earlier. This research could lead to better ways to protect women in the future, potentially saving lives in your community and beyond. When it comes to potential risks, the Mi~Scan® check requires you to be undressed from the waist up. However, a female health professional, experienced in working with women, will carry out the scan to ensure you feel comfortable. For those in the focus groups, discussing breast cancer can sometimes be upsetting, especially if you or someone you know has been affected. There are plans in place to support anyone who becomes distressed, and you'll be given information about local support organisations in Manchester. Remember, you can always change your mind and stop participating at any time.

Locations (14)

Manchester Integrative Medical Practice at Moss Side Health Centre
City only
Manchester, England
Surrey Lodge Medical Centre
City only
Manchester, England
The Arch Medical Practice
Approximate
Manchester, England
Hawthorn Medical Centre
Approximate
Manchester, England
World Harvest Christian Centre Manchester
Approximate
Manchester, England
Kath Locke Community Health and Resource Centre
Unverified
Manchester, England
Transformation Community Resource Centre
Unverified
Manchester, England
The Robert Darbishire Practice
Unverified
Manchester, England
Gorton Central
Unverified
Manchester, England
Moss Side Library and Leisure Centre
Unverified
Manchester, England
Brunswick Parish Church
Unverified
Manchester, England
Alfurqan Islamic Centre
Unverified
Manchester, England

Common questions

What is breast density?

Breast density describes how much dense tissue (glands and fibrous tissue) is in your breast compared to fatty tissue. Higher breast density can increase the risk of breast cancer.

What is the Mi~Scan® device?

The Mi~Scan® is a new desktop machine that can quickly and painlessly measure breast density without needing a traditional X-ray or mammogram.

Will I get my breast density results?

The study aims to assess the acceptability of the device, not to provide individual results for medical recommendations at this stage. Please ask the study team for more details.

Is the Mi~Scan® safe?

Yes, the Mi~Scan® device offers a painless and simple way to get a density score. The study aims to confirm its acceptability and usability.

How long will my participation take?

Your participation will involve one Mi~Scan® assessment and a short questionnaire. If you are invited to a focus group, that would be an additional session.

How to find out more

Molly Parfett

molly.parfett@manchester.ac.uk +44 (0)7535660800 Official trial record

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