A study looking at a different type of MRI scan for breast cancer (NaRNIA)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Breast cancer

Status:

Closed

Phase:

Other

The MRI scan the researchers are looking at in this study uses the salt (sodium) in the cells of the breast cancer to see what is going on inside the breast.

It is open to women having breast cancer treatment at Cambridge University Hospital NHS Trust.

The study team are also looking for healthy women to join.

More about this trial

To get a picture of your breast cancer doctors use one or more of the following tests:

In the cells of the body there is water which contains a substance called hydrogen. An MRI scan uses magnetism, radio waves and hydrogen in the cells to get information about the breast and breast cancer.

Also in the cells is a natural salt called sodium. Researchers think that an MRI scan that uses the sodium in the cells (a sodium MRI scan) might give more information than the hydrogen one.

They hope the sodium MRI scan:

will increase their understanding of how breast cancer works
help doctors to better predict how well treatment might work
help doctors to decide what is the best treatment for each person

The main aim of this study is to develop the sodium MRI scan and work out the best procedures for doing the scan.

Who can enter

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

Who can take part

You may be able to join this study if all of the following apply. You are a woman and you:

have breast cancer that is bigger than 1cm across
have had a mammogram and or ultrasound of your cancer
are at least 18 years old

For healthy volunteer women to join you must be at least 18 years old.

Who can’t take part

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

have had a serious injury to your breast in the past 3 months
aren’t able to have an MRI scan for any reason, for example you have metal implants such as a pacemaker, surgical clips, pins or plates or cochlear implants (for deafness), you have a fear of being in closed spaces (claustrophobia) or you have small pieces of metal in your eyes
have any other medical or mental health condition that your doctor or the trial team think can affect you taking part
are pregnant or breastfeeding

For women with breast cancer
You cannot join this study if any of the following also apply. You:

have had chemotherapy or hormone therapy for your breast cancer in the past year
have had surgery or radiotherapy for your breast cancer on the same side as your cancer
have had surgery to remove a non cancerous lump (benign) from your breast in the past 4 months
have or had problems with your kidneys
are allergic to the contrast medium used for the MRI

Trial design

The study needs 45 women with breast cancer to join and 20 healthy volunteer women to join.

Women with breast cancer
The number of MRI scans you have depends on what treatment you are having.

You have an MRI scan before surgery if you are having surgery first. The team will ask you to come back for a 2nd MRI scan after your surgery. This is to check if they can repeat the way the sodium MRI scan is done. You don’t have to agree to this 2nd MRI scan if you don’t want to.

You have 2 MRI scans if you are having chemotherapy before surgery. One before you start chemotherapy and then another after the 3rd or 4th cycle of treatment. You might also have a PET-MRI scan at the same time. You don’t have to agree to have the PET-MRI scan if you don’t want to.

For both the MRI scan and the PET-MRI scan you have a contrast medium. You have this through a needle (cannula Open a glossary item ) into a vein.

For the PET-MRI scan you shouldn’t eat for 6 hours beforehand. You can drink water as long as it isn’t flavoured. For 24 hours beforehand you shouldn’t do any strenuous exercise.

The MRI scan takes 60 minutes and the PET-MRI scan takes 90 minutes. You can choose to have either the MRI or the PET-MRI scan.

Tissue sample
The team will ask your permission to get a piece of cancer tissue that was taken when you had surgery or when you had a sample (biopsy Open a glossary item ) done to diagnose your cancer.

They will compare what they see in the tissue sample with what they see on the MRI scan.

Healthy volunteers
Posters of the study are displayed in Addenbrookes Hospital and around Cambridge Biomedical Campus. The contact details of the study team are on the posters. You can contact the team if you are interested in taking part. The team will tell you about the study and ask you a few questions to find out if you are suitable to join the study. They will invite you to do so if you are suitable.

As a healthy volunteer you have 1 MRI scan. This takes about 60 minutes.

Hospital visits

You have your scans at either the MRIS Unit or the Wolfson Brain Imaging Centre at the Addenbrookes Hospital.

Side effects

The radiographer will monitor you during the scans. You have a ‘squeeze ball’ alarm during the scans so you can alert them if you feel any discomfort.

MRI Scan
An MRI scan is very safe and doesn’t use radiation. Some people can’t have an MRI but the checklist picks this up beforehand. Possible risks are:

bruising where the needle went in for the cannula
the contrast medium might leak into the surrounding tissue causing swelling and pain
an allergic reaction to the contrast medium. If during the scan you feel weak, are sweating or have difficulty breathing alert the radiographer straight away

PET MRI scan
A PET-MRI scan is a safe test for most people. But like all medical tests, it has some risks. Possible risks are:

a slight increase in the risk of getting another cancer due to the radiation used in the contrast medium
kidney problems caused by the contrast medium
bruising where the needle went in for the cannula
the contrast medium might leak into the surrounding tissue causing swelling and pain
an allergic reaction to the contrast medium. If during the scan you feel weak, are sweating or have difficulty breathing alert the radiographer straight away