A study looking at a new type of mammogram to help diagnose breast cancer (CONTEND study)

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:

Pilot

This study is comparing contrast enhanced spectral mammography (CESM) with magnetic resonance imaging (MRI) to see if it is better at finding breast cancer.

It is for women:

with an abnormal area or breast lesion that needs to be looked at further
going to the Cambridge Breast Unit

More about this trial

Women between the ages of 50 to 70 are routinely screened for breast cancer using mammograms.

Doctors ask you to have more tests if they find an abnormal area or lesion. This is to rule out or confirm a diagnosis of breast cancer.

In this study, researchers are looking at a new type of mammogram called contrast enhanced spectral mammography (CESM).

CESM involves having an injection of a dye (contrast medium Open a glossary item ) into a vein of your arm before taking X-ray images of the breast.

Doctors think CESM can give a more accurate and detailed image of the breast than a normal mammogram. So it might reduce the need to have more tests to confirm a diagnosis of cancer.

In this study, women will have one of the following:

standard care – this might include a physical examination, mammogram, ultrasound scan, MRI scan and biopsy
CESM and standard care

The main aims of this study are to:

find out if CESM can help diagnose breast cancer
see if CESM is as good as an MRI scan at finding breast lesions
see if CESM can reduce the number of false positive results

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.

You may be able to join this study if you are a woman going to the Cambridge Breast Unit and all of the following apply

You are aged 18 years or over
You have an abnormal area or breast lesion and you need to have more tests

You cannot join this study if any of these apply

You have breast implants
You have had breast cancer
Your kidneys don’t work very well
You are known to be sensitive to the injection given during an MRI scan (contrast medium) or you have had a scan with contrast medium in the last 24 hours
You have already started anti cancer treatment (such as surgery, chemotherapy or radiotherapy)
You are pregnant

Trial design

This is a pilot study. Researchers need about 100 women going to the Cambridge Breast Unit to take part.

This study is randomised. People taking part are put into 1 of the following groups by a computer:

CESM and standard care
Standard care

Neither you nor your doctor will be able to decide which group you are.

Diagram showing trial design for CONTEND

CESM and standard care
You will be asked to complete a questionnaire first. It will ask about your health and if you have had any problems with scans in the past.

After this you have the mammogram (CESM). A sample of cells (biopsy) will be taken if necessary.

After the CESM you might have other tests that would be part of standard care, such as an MRI scan. Your doctor will explain if any other tests are needed.

Standard care
As part of standard care you might have:

a physical examination
another mammogram
an ultrasound scan
an MRI scan
a biopsy

Your doctor will explain what tests you need.

Hospital visits

If you have CESM and standard care, you might have 1 extra visit to the Cambridge Breast Unit. All other tests are part of your normal care.

Side effects

The possible side effects of CESM are:

pain at the contrast medium injection site
sensitive reaction to contrast medium
feeling or being sick

You also have an extra dose of radiation Open a glossary item . The amount of extra radiation you have is the same that you get during a flight to New Zealand or 20 chest X-rays. The research team doesn’t think this will cause any problems to your health.

We have more information on having an MRI scan