Taking part in the FAST MRI DYAMOND study

Women with “average” breast density and a clear mammogram may be able to have a FAST MRI. To find this out, we are first inviting women to Stage 1 of the DYAMOND study. 

If you agree to take part in Stage 1, we will send your mammogram to the DYAMOND team at the Royal Surrey NHS Foundation Trust so that they can measure your breast density. We won’t send your mammogram to be measured for 10 working days after we receive your consent. This is in case you change your mind about participating. If you do, please let us know. 

The results will then be sent to Warwick Clinical Trials Unit, to be stored. 

If your mammogram is measured as anything other than average breast density, you will be looked after by the screening service, and you won’t be able to take part in this study. This is because we are only inviting people with “average” breast density to have a FAST MRI.

If your mammogram measurement is in the “average” breast density group, we will look at your mammogram screening results to check if the screening service says you need any further investigations. This is because in this study, we are only inviting people with clear mammograms to have a FAST MRI.

If you do need some further investigations, the screening service will contact you directly. You won’t be able to have the FAST MRI scan as part of this study. Instead, with your consent, we would like to access your screening and medical records to discover the outcome of your investigations. We will do this for up to 3 years after your first mammogram.

If the screening service says your mammogram needs no further investigations and you are in the average breast density group, we will send you information and an invitation to take part in Stage 2 of the study.

Agreeing to take part in Stage 1 does not mean you will automatically have a FAST MRI scan. If the Stage 1 density grading shows you are eligible to take part in Stage 2, you will be invited and can then decide whether to take part or not. 

No, it’s up to you to decide whether to take part. If you do not want a FAST MRI scan or know you cannot have one, then you can let us know you don’t want to take part. Whether or not you choose to take part, be reassured that your clinical care will not be affected. You will still be offered your routine screening mammograms every 3 years until you turn 71.

Following your first mammogram, we invited you to take part in Stage 1 of the DYAMOND study: to measure your breast density and to check your breast screening results. Your images have now been checked and we think you could be eligible to join Stage 2 of the study to have a FAST MRI scan. 

No, it’s up to you to decide whether to take part. If you choose not to, be reassured that your clinical care will not be affected. You will still be offered your routine screening mammograms every 3 years until you turn 71. 

We have designed the study to be as convenient as it can be, so that as many people can be involved as possible. If you decide to take part, we will:

• Ask you some questions about your health
• Check that you can have a FAST MRI scan 
• Book a FAST MRI scan at a time convenient to you
• Ask you to complete a survey about your experience

Some people may also be invited to take part in an interview about their experience.

We expect a small proportion of people having a FAST MRI scan to be invited for another scan after a year or be referred for further investigations.

A Research Nurse will contact you to discuss this part of the study and answer any questions you may have. If you would like to join the study, they will ask you some questions about your health to make sure that you are safe to have the FAST MRI scan. They will help you complete an online consent form and book you in for your scan at a time convenient to you. This will need to be between day 6 and 16 of your cycle if you are still having regular periods.

Please let the Research Nurse know if you are affected by any of the below as these things may prevent you having an MRI scan:

• If you are or may be pregnant or if you are breast feeding 
• If you have ever had a penetrating eye injury
• If you have ever had brain surgery
• If you have a pacemaker or defibrillator
• If you have an implanted neurostimulator
• If you have a cochlear implant
• If you have ever had a shrapnel injury
• If you are claustrophobic
• If you have had conditions associated with your kidneys
• If you wear a sensor to measure your blood sugars (e.g. a “continuous glucose monitor”), this will need to be removed for the scan. We will try to arrange your scan around the time when you are due to change your sensor.

We encourage you to watch this video to see what it is like to have a FAST MRI scan. 

Your FAST MRI scan appointment will take up to 45 minutes.

When you arrive, the radiographer will ask some questions to confirm that it’s safe for you to have the scan and ask you to sign a standard safety checklist. 

You will be asked to change into a hospital gown. 

You will have a cannula (a small, soft plastic tube) placed into a vein in your arm. This is necessary so that the radiographer can inject dye during your scan, which makes a cancer show up clearly if it’s there. The injection of dye is not painful. 

The radiographer will explain what is going to happen during the scan, which we expect to take between 3 and 5 minutes.

Once you have had the scan and your cannula has been removed, you will be free to go. Your scans will be sent to specialists who look at them in detail and check the findings. This means we can’t give you the results on the day of your scan.  

We will let you know the results of your FAST MRI scan 3-4 weeks after your scan date. 

If your scan is clear, you will receive your scan results by letter. 

Some people with a clear FAST MRI scan may be invited to have another scan in a year's time. This is because their scan is most likely normal but we would like to see if it has changed over time, as we are still learning which appearances on FAST MRI we can confidently call “clear”. We expect that all the people invited to have this second scan will then have a clear result.

If your scan shows that further investigations are needed, a Research Nurse will contact you by telephone to explain the results and what will happen next. The Research Nurse will arrange an appointment at the Breast Care Clinic. Appointments are usually offered within about 2 weeks of referral. This does not necessarily mean that you have a breast cancer, just that you need to have additional tests. You will receive a letter confirming the FAST MRI scan results.   

At these appointments a healthcare professional will look at your mammogram and FAST MRI scan results and will ask for more tests to be done, including another scan and possibly a biopsy. If you have a biopsy, we may ask you if we can collect an extra sample to donate to a tissue bank to help support future research. Information about this option will only be sent to you if you need further investigations following your FAST MRI.

They may also discuss your case with a team of other professionals after your appointment to help decide if more investigations are needed, which could include deciding to perform a full MRI. If you do need further tests, your care team will explain why each test is important and what having the test would involve for you. Any extra tests you may have will help the team decide if what was seen on the FAST MRI is a cancer or not.

We expect that if 100 people have a FAST MRI scan, 5 of those people will be called back for further investigations. Of those 5 people, we expect that only around 1 participant will be diagnosed with a cancer.

Taking part in the FAST MRI DYAMOND Study gives you access to a new test (a FAST MRI scan).

We do not know if your FAST MRI scan will pick up a cancer that was not found on your first mammogram. If it does, it is possible that you will have a better outcome, because the cancer will have been found earlier than it would have been if you had not taken part in the study. 

By taking part in this important study, you will be making a difference by helping us plan more research to improve breast screening for everyone in the future.

We expect that the potential advantages of taking part will outweigh any disadvantages or risks.

Having an MRI scan is painless, and it’s one of the safest medical procedures available, but there are some risks. For example, there are increased risks to people with certain implants or foreign bodies. The Research Nurse and Radiographer will ask you questions about your medical history to check that you can have the scan. 

Some patients occasionally experience a tingling sensation or feel hot from being in the MRI scanner. These effects only last a short while and should ease as soon as the scan is over.

The scan involves having an injection of dye which is used to highlight any cancer cells (if a cancer is there). The risks associated with this injection are small and are well known: 

• About 1 in every 100 people may have a mild reaction to this dye (such as pain at the injection site, nausea or headache) 
• About 1 in 1000 people may experience vomiting and/or an itchy rash   
• A more severe allergic rection is very rare, affecting about 1 in 10,000 people.  The radiographers who will be looking after you during your FAST MRI scan are trained to support individuals if this happens, and appropriate medical care will be given.  The dye is not recommended for people who are pregnant or breast feeding.
• Tiny amounts of dye can stay in the body for a long time after the scan but this has never been shown to cause any problems.   

If you decide to take part in the study, we will let your GP know and we will tell them the results of your scan when they are available.

You will not be paid for taking part in the FAST MRI DYAMOND study but reasonable expenses (up to £10) to attend your FAST MRI scan will be covered. Your Research Nurse will give you this information.