“Deborah agreed to take part in a trial as she was keen to help other cancer patients in the future. "If taking part in a trial means others might be helped then I’m very happy with that."
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.
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
- Are pregnant
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
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
The radiographer will do the tomosynthesis at the same time as your mammogram. It will add another 5 to 10 minutes to your visit.
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.
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.
Dr Anthony Maxwell
Genesis Breast Cancer Prevention Centre
NIHR Clinical Research Network: Cancer
University Hospital of South Manchester NHS Foundation Trust