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.

Cancer type:

Breast cancer

Status:

Closed

Phase:

Other

This study is comparing 2 different ways of taking samples of tissue (biopsy) from lymph nodes under the arm.

Lymph nodes are a part of your lymphatic system. Lymph nodes drain away waste fluid, waste products and damaged cells from the body tissues. If cells break away from a cancer, they often get stuck in the nearest lymph nodes. This is why doctors often check lymph nodes closest to the cancer. If you have breast cancer doctors check the lymph nodes under your 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 biopsy). They put a needle into the lymph node and take out some cores of tissue. This is called a needle, or core, biopsy.

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.

Radiologists sometimes use vacuum biopsy to take a sample of tissue from breast cancer. But vacuum biopsy has not been widely used to take a sample of tissue from the lymph nodes under the arm.

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 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

Trial design

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

trial diagram

Before the biopsy, you have a local anaesthetic to numb the area. Both types of biopsy take a few minutes. The researchers will take at least 3 samples of tissue.

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.

Hospital visits

There are no extra visits to the hospital as part of this study.

Side effects

The complications of both types of biopsies may include

  • Pain
  • Infection
  • Bleeding
  • Bruising

Your doctor will talk to you about the possible complications before you have your biopsy.

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

British Society of Breast Radiology (BSBR)
NIHR Clinical Research Network: Cancer
University Hospital Southampton NHS Foundation Trust

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11126

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:

Rate this page:

No votes yet
Thank you!
We've recently made some changes to the site, tell us what you think

Share this page