“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”
A study comparing two ways of taking samples of tissue from lymph nodes under the arm
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is comparing 2 different ways of taking samples of tissue (biopsy) from lymph nodes under the arm.
Doctors usually check these lymph nodes with an ultrasound scan. If the scan shows that one or more of the nodes is thickened they will examine it further by taking a small piece of tissue (a
Vacuum biopsy is another way of taking a biopsy. After putting the needle into the lymph node, the doctor uses suction to take a sample of tissue. This sample of tissue is slightly larger than that taken by a needle biopsy.
The researchers want to compare using vacuum biopsy with needle biopsy for taking samples of tissue from lymph nodes.
The aims of this study are to find out
- How safe and acceptable it is to do vacuum biopsy of the lymph nodes under the arm
- If it might be possible to do a larger study to compare vacuum biopsy with needle biopsy to find out which is best
Who can enter
You may be able to enter this trial if you are a woman in one of the following situations
- You have had a mammogram, ultrasound or MRI scan that shows there is a high chance that you may have breast cancer
- You have breast cancer
You must also
- Have had a lymph node ultrasound that shows the cancer, or suspected cancer, may have spread to the lymph nodes under your arm
- Be over 35 years old
You cannot enter this trial if
- You are taking medication that thins your blood, for example warfarin
- You have a medical condition that may stop your blood from clotting properly
- You have already had surgery to the armpit where the lymph node spread may be
- The suspected lymph node is unsuitable for vacuum biopsy because it is close to an important structure of your body, for example a major blood vessel
This is a feasibility study. It will recruit 80 women.
It is a randomised study. The women taking part are put into 1 of 2 groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
- Women in group 1 have the needle biopsy
- Women in group 2 have the vacuum biopsy
Before the biopsy, you have a
If you are in the group having the needle biopsy, they will have to remove the needle and put in again for each sample.
If you are in the group having the vacuum biopsy, they won’t have to remove the needle for each sample.
You complete a short questionnaire about your experience of having the biopsy immediately afterwards and again when you get the results.
There are no extra visits to the hospital as part of this study.
The complications of both types of biopsies may include
Your doctor will talk to you about the possible complications before you have your biopsy.
How to join a clinical trial
Dr Anthony Maxwell
British Society of Breast Radiology (BSBR)
NIHR Clinical Research Network: Cancer
University Hospital Southampton NHS Foundation Trust