A study comparing digital breast tomosynthesis with standard mammogram in screening younger high risk women

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 comparing digital breast tomosynthesis with a standard mammogram for screening young women at high risk of breast cancer.

Mammograms are used to screen for breast cancer. You may be at higher risk because you have a family history of breast cancer or a gene fault in your family. But there can be problems with using mammograms. One problem is that it can be difficult to tell the difference between what may be cancer and what isn’t. So some women will need to have more tests to find out.

More about this trial

Tomosynthesis (pronounced tom-oh-sin-ther-sis) is an advanced type of mammogram. It uses digital X-rays and a computer to put together a 3D picture of the breast. We know from early research that tomosynthesis should give a more accurate and detailed picture of the breast than the standard mammogram. If so this should reduce the need for other tests to rule out or confirm a diagnosis of cancer.

The aims of this study are to compare the standard mammogram with tomosynthesis to find out which is more accurate for diagnosing breast cancer in younger high risk women and to see if tomosynthesis can reduce the number of false alarms which can lead to further tests.

Who can enter

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

  • You have an increased risk of developing breast cancer due to your family history
  • A family history clinic or genetics service has referred you for breast cancer screening at the Nightingale Centre, Manchester or King’s College Hospital, London
  • You are between 40 and 49 years old

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

  • Have had breast cancer in the past
  • Have breast implants
  • Are pregnant

Trial design

The study team need 2,900 women who are going to the Nightingale Centre, Manchester or King’s College Hospital, London to join.

There are 2 parts to this study (part A and part B). Which part you are in depends on whether or not you have had a mammogram in the last 5 years.

Part A is for women who have had a mammogram in the last 5 years. This part is randomised. You are put into 1 of 2 groups by a computer. Neither you nor your radiographer will be able to decide which group you are in.

  • Women in group 1 will have a mammogram and tomosynthesis
  • Women in group 2 will have a mammogram only

11891 Trial Diagram

A year later, you have another mammogram. If you were in group 2, you will have the mammogram and tomosynthesis. If you were in group 1, you have a mammogram only. You will continue to have a mammogram as long as you are in the age group for screening.

Part B is for women who haven’t had a mammogram in the last 5 years. Everybody joining this part of the trial will have a mammogram and tomosynthesis. You will continue to have a mammogram as long as you are in the age group for screening.

Your mammograms will be looked at by an experienced breast radiologist or breast doctor. You will be sent a letter informing you of the outcome of the mammogram within three weeks of your visit and if you may need to have further tests.

Hospital visits

The radiographer will do the tomosynthesis at the same time as your mammogram. It will add another 5 to 10 minutes to your visit.

Side effects

Women find mammograms anything from mildly uncomfortable to painful. Having tomosynthesis is very similar to having a mammogram, so any discomfort you normally have with a mammogram will be the same.

Taking part in the study means that you will be exposed to the same amount of radiation as 2 mammograms in a row. The team doesn’t think this will cause any problems to your health.

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

Dr Anthony Maxwell

Supported by

Genesis Breast Cancer Prevention Centre
NIHR Clinical Research Network: Cancer
University Hospital of South Manchester NHS Foundation Trust

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11891

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

A 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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