A study looking at x-ray mammography and MRI in women at different levels of risk of developing breast cancer

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

This study is for premenopausal women aged 39.5 to 50.5 years who have healthy breast tissue on a mammogram.

It will compare the mammograms and MRI scans of women who were investigated for symptoms and had normal breast tissue on a scan, in women at high and low risk of developing breast cancer.

More about this trial

X-ray mammography is the usual test in the NHS breast screening programme. Women with symptoms needing investigation might also have one.

Women who are at high risk of breast cancer might have MRI scans to screen them. This includes women carrying a BRCA 1 or BRCA 2 gene mutation, or those who had radiotherapy for Hodgkin lymphoma at an early age.

Researchers aim to develop new MRI techniques to improve measurements that might affect breast cancer risk. These include measuring:

breast tissue density
breast tissue blood supply

Researchers will compare breast tissue characteristics assessed by imaging in women at high and low risk of breast cancer.

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

Royal Marsden x-ray mammography patients may be invited to join this study if all of the following apply. You:

are 39.5 to 50.5 years old
have healthy breast tissue on x-ray mammography
are premenopausal (have not had your menopause)
able to have an MRI scan within 6 weeks of your mammogram

Who can’t take part

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

had breast cancer
are taking hormone treatment (including the oral contraceptive pill)
had your ovaries and fallopian tubes removed on both sides
have breast implants that are not compatible with having an MRI scan
are claustrophobic
have kidney problems
are not able to have an MRI scan. This may be because you have certain types of metal surgical clips or plates in your body, or you have a pacemaker or might be pregnant

Trial design

This study is in 2 parts.

Part 1

Researchers are looking back at scans of women who had symptoms, but normal breast tissue in at least one breast (shown on mammogram).

They will compare breast characteristics with scans of women attending screening with a high risk of breast cancer. This includes women:

with a BRCA 1 or BRCA 2 gene mutation
who had mantle radiotherapy for Hodgkin lymphoma at an early age

Part 2

Recruitment is for part 2 of this study. The study will recruit about 30 women.

Researchers will compare the breast characteristics on the mammograms and MRI scans of women at low risk of breast cancer. And compare this group with the group at high risk of developing breast cancer.

Hospital visits

Participants attend one outpatient appointment for an MRI scan. This happens within 6 weeks of your mammogram.

The appointment is usually about 1 hour.

Side effects

MRI scans are a routine test. It is a safe test.

Rarely, the injection (contrast medium) used in the MRI scan might cause:

nausea
headache
an allergic reaction

Sometimes the scan shows an abnormality, but no cancer is found when you have further tests. This is called a false positive result.

Doctors will discuss any unexpected results with you, and would give the support you need, such as further tests or treatment.

Recruitment start:

01/04/2017

Recruitment end:

30/11/2019

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.

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Questions to ask your doctor about clinical trials

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

Chief Investigator

Dr Steven Allen

Supported by

NIHR Clinical Research Network: Cancer
Royal Marsden NIHR Clinical Research Facility
The Royal Marsden NHS Foundation Trust

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Email

Last review date

10 December 2019

CRUK internal database number:

12648