A study looking at a new type of mammogram called digital breast tomosynthesis

This study is comparing a test called digital breast tomosynthesis with a standard digital mammogram. It is for women under 60 years of age.

A mammogram is a test that doctors use to diagnose breast cancer. But in younger women, the breast tissue can be dense and a mammogram can be less accurate.

In this study, researchers are looking at a new technique called digital breast tomosynthesis (DBT). DBT takes more X-rays than a standard mammogram and a computer uses these to create a 3 dimensional (3D) image.

The women taking part in the study are attending a specialist breast clinic and are going to have a mammogram. The aim of the study is to see if DBT is better than standard digital mammography at finding breast cancer in women under 60.

Recruitment

Start 07/03/2011

End 28/02/2013

Phase

Other

Who can enter

You can enter this study if you

Are attending the breast clinic at Ninewells Hospital in Dundee and you are invited to take part because there is a possibility you may have breast cancer
Are female and are between 25 and 59 years old

You cannot enter this study if

Your doctor can see that you have locally advanced cancer
You have another serious medical condition that means you would not be able to have surgery
You are pregnant or breastfeeding

Trial design

The study will recruit about 200 women. Everybody taking part will have a standard digital mammogram and digital breast tomosynthesis.

When you have a mammogram, your breast is pressed firmly against a plate on the X-ray machine by a plastic paddle. If you agree to take part in the study, the pressure will be for a few seconds longer. This is to allow the X-ray machine to take more pictures. Part of the X-ray machine will move, but it will not touch you.

The doctors will use the results of the mammogram and DBT to decide if there is anything wrong with your breasts. You may also need to have other tests for breast cancer.

After your clinic appointment, your personal involvement in the study finishes. But the researchers will use the images and relevant details from your medical notes to work out if DBT is more accurate than standard mammography.

Hospital visits

Taking part in this study does not involve any extra hospital visits.

Side effects

As having DBT takes a little longer than a standard mammogram, it may be more uncomfortable.

The amount of radiation to the breast is higher in the mammogram with DBT than in the standard mammogram. The potential radiation risk has been assessed by a medical physics expert who has calculated that the risk of the extra radiation causing a breast cancer is thousands of times smaller than the natural lifetime risk of breast cancer which women already have.

It is possible that DBT may raise concerns about an area of the breast that turn out to be nothing serious. Rarely, this could lead to some women having a needle biopsy that would not have been recommended for them if they were not taking part in the study.

Because the images will be looked at again after your clinic appointment, it is possible that something could be spotted later that was not seen in the clinic. If this happens, the doctors will ask you to go back to the clinic and may want you to have more tests. This could lead to extra anxiety, but may also be seen as an extra safety net.