A study comparing breast scans to diagnose small breast cancers in dense breasts (BRAID)

There are 2 stages to this trial. 

Pilot study - closed

The 1st stage is a pilot study. The team need 1,200 women to join. You have one of the following scans:

• Automated Whole Breast Ultrasound (ABUS) 
• Contrast Enhanced Spectral Mammography (CESM)
• Abbreviated Breast Magnetic Resonance Imaging (ABB-MRI)

Your radiologist decides which scan you have. 

Randomised trial
The 2nd stage is a randomised trial. The team need 8,400 women to join. Which group you are in is chosen at random. Neither you nor your radiologist choses which group you go into. 

• 2,100 women have ABUS.
• 2,100 women have CESM.
• 2,100 women have ABB-MRI.
• 2,100 women have the standard mammogram. 

BRAID study randomisation diagram

Centres taking part in the trial identify women who have dense breasts. They then invite these women to take part in the trial. This means they ask you to join following your normal screening mammogram. 
 
ABUS
You lie on your side on the examination table. You have pillows behind your back and a head rest to make sure you are comfortable. The radiographer spreads a layer of lotion or gel over your breast. They place the scanner over your breast. 

A microphone automatically moves from one side of your breast to the other. This takes 30 seconds. The radiographer moves the scanner so it can take another image from a different angle. Depending on the size of your breast this might happen 3 or 4 times. 

It takes about 15 minutes to scan both breasts. After this you can go home. 

CESM
For women who are still menstruating the health professional asks you about your menstrual cycle. This is to work out when to have the 1st scan done. You should have the scan between days 6 and 16 of your cycle and within 6 months of having your original screening mammogram. A member of the research team will tell you when and where you have the scan. 

On the day of the scan you fill in a short medical questionnaire. This asks about:

• your health
• any allergies
• any previous examinations using a contrast dye  (medium)

You might have a finger prick blood test to check how well your kidneys are working. 

The radiographer puts a thin tube (cannula ) into a vein. You have the contrast dye through the cannula. After 2 minutes the radiographer positions you for the mammograph. They take 4 images of your breasts. This is the same as having an ordinary mammogram. 

The whole procedure takes about 10 minutes. 

You stay in the scanning department for 15 minutes after the scan. This is to make sure you don’t have an allergic reaction to the contrast dye. The cannula stays in for at least 5 minutes. After 15 minutes the radiographer removes the cannula then you can go home. 

ABB-MRI
For women who are still menstruating the health professional asks you about your menstrual cycle. This is to work out when to have the 1st scan done. It should be between days 6 and 16 of your cycle. And within 6 months of having your screening mammogram. A member of the research team will tell you when and where you have the scan. 

Before the ABB-MRI you need to tell the radiographer if you have any of the following:

• any surgical implants
• cochlear implants
• any electronic devices in your body such as a pacemaker
• artificial heart valves
• clips on arteries especially after brain surgery

This is for your safety. But you should still be able to have the scan. 

You go through a safety check list with the radiographer before the scan. Do not take any metal in to the scanner room with you. Don’t wear any make up on the day of the scan as it can contain metal. 

Before the scan you change into a gown and the radiographer puts a thin tube (cannula) into a vein. 

You lie face down on the MRI couch. The radiographer helps you put your breast in the holes of the couch. Tell the radiographer if it is uncomfortable because you need to be still during the scan. They will make it comfortable for you. You have earplugs or headphones to use as the MRI scan is noisy.

When you are ready and in position the couch slides into the scanner. And the scanning begins. The radiographer is in the control room where they control the scanner.

You have a pump connected to the thin tube in your vein. Near the end of the scanning the radiographer uses this to pump contrast dye into your vein. You might feel a cold sensation when this happens.  

You have standard mammograms as usual. 

Questionnaires
You fill in a CanRisk questionnaire once. The questions ask about your personal risk of getting breast cancer and your family history. 

Samples
You give a sample of your spit (saliva). You spit into a tube until there is enough spit without any bubbles in it. This can sometimes take about 10 minutes.  

You can’t eat, smoke or drink anything apart from plain water for 30 minutes before you give the sample. 

They will store these samples for future research. 

You do not have to give these samples if you don’t want to. You can still take part in the trial. 

Women who need to come back (recalled)
After your routine screening mammogram you might need to have other scans for further assessment. In this case you then have a choice about how you can take part in the randomised trial. 

You can take part in the full randomised trial as set out above or you can choose not to.

By choosing not to take part in the full randomised trial you won’t go into a group or have the scans. But you can agree to the researchers looking at your medical records. This is so they can see the results of your further assessments.

You can also agree to:

• fill in the CanRisk questionnaire
• give the spit (saliva) sample

But you don’t have to agree to these if you don’t want to.

As you aren’t having any of the research scans done you won’t have any extra visits to the hospital.