CompletedNot ApplicableInterventional

A prospective study to assess the impact and benefits of an artificial intelligence system in double reading for breast cancer screening

In the UK, two specialists normally look at every routine breast screening X-ray (mammogram) to check for signs of cancer. This study is testing an artificial intelligence (AI) tool called Mia to see if it can help support these human readers. Women aged 49 to 70 attending routine breast screening at Leeds Teaching Hospitals can take part. Half of the women will have their scans reviewed by two specialists as normal. The other half will have their scans checked by the two specialists and the AI software working in the background. Taking part does not involve extra hospital visits, additional X-rays, or medications. You will receive your results in the usual way. Researchers want to find out whether AI can safely help doctors detect early breast cancer without causing unnecessary worry or extra hospital appointments.

At a glance

Status

Completed

Phase

Not Applicable

Sponsor

Kheiron Medical Technologies (United Kingdom)

Enrolment target

6,876

Start

31 Oct 2023

Estimated completion

29 Feb 2024

Breast cancer

What is this study about?

In the UK, the NHS Breast Screening Programme invites women aged 50 to 70 for regular breast X-rays, called mammograms. To make sure nothing is missed, two qualified healthcare professionals look at each scan. While this double-checking system works well, human eyes can occasionally miss very small or subtle changes in breast tissue.

Researchers are now testing a new computer tool called Mia, which uses artificial intelligence (AI). Mia has been trained to recognise patterns that could indicate early signs of breast cancer. In this study, Mia looks at mammograms in the background alongside the human specialists to see if it can help them work more effectively.

Finding breast cancer early gives people the best chance of successful treatment. By comparing scans checked with and without AI, this study will show whether AI can help doctors catch more cancers early and how it might fit into normal NHS screening in the future.

Key takeaways

Tests an AI tool called Mia to assist specialists during routine breast screening.
Open to women aged 49 to 70 having screening at Leeds Teaching Hospitals.
Requires no extra appointments, tests, or changes to your normal visit.
Half of scans are checked by two specialists; half by two specialists plus AI.
Aims to find out if AI can help detect breast cancer earlier.

Who may be eligible?

You may be eligible for this study if you are a woman aged between 49 and 70 attending routine NHS breast screening at Leeds Teaching Hospitals. Your visit must include a standard set of four clear X-ray images.

This study is not suitable for women who have cosmetic breast implants, or those known to have a very high personal risk of breast cancer (such as carrying specific altered genes). It is also not suitable if your scan needs to be repeated for technical reasons, or if you choose not to take part.

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 am a woman aged between 49 and 70.
I am having routine breast screening at Leeds Teaching Hospitals.
I am having a standard set of four mammogram X-rays.
I do not have cosmetic breast implants.
I do not have a known very high genetic risk of breast cancer.

Answer every question to see your result.

What does participation involve?

Taking part does not change your routine screening appointment. You will not need any extra visits, extra X-rays, or any medication. A computer will randomly decide whether your scan is reviewed by two human specialists alone, or by the two specialists with the AI tool assisting them in the background. You will receive your results by post as normal. If everything looks healthy, you will be invited back for routine screening in three years. If an area needs further checking, you will be invited for standard follow-up tests.

Potential risks and benefits

The main possible benefit is that the AI tool might help doctors spot a small cancer that could otherwise have been missed, allowing treatment to start sooner. The main risk is that using AI might mean slightly more women are asked to return for follow-up tests, which can cause worry. However, most women called back for extra tests do not have breast cancer. You have the right to opt out at any time, and doing so will not affect your normal NHS care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Leeds Teaching Hospitals NHS Trust
City only
Leeds, England

Common questions

Will an AI computer replace my doctor?

No. Two trained human specialists will always look at your scan. The AI tool simply works in the background as an extra helper.

Do I need any extra scans or appointments?

No. Your breast screening appointment will go ahead as normal, and you will not need any additional X-rays or hospital visits.

How will I find out my results?

You will receive your results by letter in the post, in the exact same way as any standard NHS breast screening appointment.

What happens if I am called back for more tests?

Being called back does not mean you have cancer. Around 4 in every 100 women are called back after screening, and the vast majority turn out to be clear.

Can I choose not to have AI look at my scan?

Yes. You can choose to opt out of the study, and your mammogram will simply be reviewed by two human specialists as normal.

How to find out more

Annie Ng

annie@kheironmed.com +44 (0)7379467701 Official trial record

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