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

Cancer type:

Breast cancer

Status:

Open

Phase:

Phase 2/3

This study is to find out whether extra scans with one of several types of scans, is helpful in diagnosing breast cancer in women with dense breast tissue. 

We will do this by comparing breast cancer detection between:

  • women who have their standard 3 yearly mammograms and
  • women who have the standard 3 yearly mammogram plus two additional scans in between NHS breast screening rounds 

The study is open to women who have had breast screening as part of the NHS Breast Screening Programme. You are invited to take part if you have a high amount of dense breast tissue. 

Cancer Research UK supports this trial.

More about this trial

When you go for breast screening you have a standard 2 dimensional (2D) mammogram

We know that with the standard mammogram it is difficult to diagnose small cancers in women who have dense breasts. So researchers are looking for ways to make this easier. 

In this study they are looking at 3 different types of scans:

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

Automated whole breast ultrasound uses sound waves. It creates a 3 dimensional (3D) image of your breast. It is similar to an ultrasound Open a glossary item. The machine moves the microphone around your breast instead of the specialist (sonographer). 

Contrast enhanced spectral mammography is similar to a screening mammogram. The difference is you have an injection of a contrast dye Open a glossary item. This dye shows the difference between normal and abnormal tissue.

Abbreviated breast magnetic resonance imaging is similar to having a breast MRI scan Open a glossary item. A breast MRI scan usually takes about 30 minutes but this is too long for its use in screening. ABB-MRI for screening takes about 15 minutes. 

There are 2 stages to this trial. 

The 1st stage is a pilot study. The aims of the pilot study are:

  • for radiographers to gain experience of using these 3 scans
  • to find out if it is possible to do a larger trial as part of the NHS breast screening programme

This stage is now closed. 

The 2nd stage is a larger randomised trial Open a glossary item. In this trial researchers will compare the standard mammogram with the other 3 types of scans. They want to find out which is best at finding small cancers in women with dense breasts.

Who can enter

The following bullet points list the entry conditions for the pilot study and the randomised trial. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you. 

Pilot study - closed

Who can take part in the pilot study

You may be able to join the pilot study if all of the following apply. You are a woman who has had a screening mammogram and:

  • you have dense or very dense breast tissue 
  • you need to come back for further scans
  • you can continue to have 3 yearly screening as part of the NHS Breast Screening Programme
  • you are able to give informed consent Open a glossary item
  • you are between 50 and 70 years old

Who can’t take part

You cannot join the pilot study if any of these apply. You:

  • have a BRCA gene change (mutation Open a glossary item) or that you have a half (50%) or more chance of having a BRCA gene change 
  • have breast implants 
  • are pregnant or breastfeeding 

Randomised trial

Who can take part in the randomised trial

You may be able to join the trial if all of the following apply. You are a woman who:

  • had a screening mammogram 
  • has dense or very dense breast tissue
  • can continue to have 3 yearly screening as part of the NHS Breast Screening Programme
  • are able to give informed consent
  • is between 50 and 70 years old

Who can’t take part in the randomised trial

You cannot join this trial if any of these apply. You:

  • have a BRCA gene change (mutation) or that you have a half (50%) or more chance of having the BRCA gene change 
  • have breast implants
  • are taking part in another breast screening trial that is similar
  • took part in the pilot study for BRAID
  • are pregnant or breastfeeding

Trial design

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. 

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 Open a glossary item (medium)

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

The radiographer puts a thin tube (cannula Open a glossary item) 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.

Hospital visits

You see the doctor and have a mammogram before taking part in the pilot study or the randomised trial.

Pilot study
You have an extra scan. This is as soon as possible after your mammogram. But could be up to 6 months after. 

Randomised trial
You have your extra scans at:

  • 6 months
  • and between 15 months and 21 months

Women in the ABB-MRI and ABUS group have a standard mammogram at 18 months. 

Researchers will continue to follow you as long as you are in the NHS Breast Screening Programme. But this won’t mean any extra visits. 

Side effects

The team monitor you during your scans and for a short time afterwards. During the scans if you feel unwell or uncomfortable tell the radiographer. 

Once you’re home contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better. 

The scans used are safe procedures. For the CESM and the ABB-MRI you have a contrast dye.

Common side effects of the contrast dye used in the ABB-MRI include:

  • headache
  • feeling sick

Common side effects of the contrast dye used in the CESM include:

  • feeling hot
  • changes to your breathing that is either breathing faster or slower than normal 

The dyes can also cause an allergic reaction. This usually happens very soon after the injection of the dye. Symptoms can include:

  • skin rash, hives and itching
  • feeling or being sick
  • dizziness
  • runny nose
  • headache
  • wheezing
  • heart palpitations
  • swelling of the face
  • high blood pressure 
  • tummy (abdominal) cramps

Tell the radiographer if you have any of these after you have had the injection of the contrast dye. 

A member of the research team or your doctor will talk about the possible side effects of having these scans before you agree to take part. 

Location

Cambridge
Cheltenham
Dundee
Glasgow
Leeds
Leicester
London
Manchester

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Fiona Gilbert

Supported by

Cambridge University NHS Foundation Trust
University of Cambridge
Cancer Research UK
GE healthcare
Bayer Pharmaceuticals
 

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16761

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Harriet wanted to try new treatments

Picture of Harriet

“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”

Last reviewed:

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