For patients

Thousands of people are told that they have breast cancer every year in the UK and most will need an operation to remove the cancer. As well as removing the cancer in the breast, they are advised to have some or all of their lymph nodes removed from the armpit. As most people have early stage breast cancer, only 3/10 will have cancer deposits in the lymph nodes. This means that many people are having unnecessary surgery to the armpit. The risks of removing lymph nodes from the armpit include infection, bleeding and fluid collections as well as arm swelling, loss of feeling or sometimes pain down the arm. There is already a lot of effort to reduce armpit surgery and better use of ultrasound may help to identify patients who don’t need this surgery at all.

We are planning to train specialists from five hospitals to use ultrasound with injected microbubbles to find the sentinel (key) lymph nodes in the armpit. The specialist can then take a needle biopsy to see if the sentinel lymph nodes contain cancer deposits. We will also look at how satisfied patients are with the procedure and check for problems like bleeding after the biopsy. If this research is successful, microbubbles and ultrasound biopsy of sentinel lymph nodes may be able to replace armpit surgery for many breast cancer patients.

Microbubbles are tiny gas filled bubbles that are smaller than a red blood cell. The hexafluoride gas in the microbubbles is harmlessly removed from the body by the lungs. They have been used for many years to look at blood flow in arteries and internal organs by injecting them into the bloodstream. Over the last 10 years, hospitals in the UK and other parts of the World have injected them into the breast tissue to find sentinel lymph nodes.

The microbubbles procedure has been performed on more than 2,000 patients at Maidstone and Tunbridge Wells Hospitals in Kent and is very safe. Very few people experience irritation or allergy to the injected microbubbles (about 1/1000) and there have been few problems with bleeding after the biopsy (less than 1/100).

All women above the age of 18 who have recently been told that they have early breast cancer with normal looking armpit lymph nodes on a regular ultrasound can be involved in the study.

We are planning to run the study for 2 years and involve a total of 250 women.

Your breast cancer treatment will happen normally. The only difference is that you will also have the procedure using microbubbles and ultrasound to biopsy sentinel lymph nodes before your operation.

• If you agree to take part, you will need to come back for an extra visit to your breast unit’s ultrasound department to have the microbubbles procedure. The imaging specialist will use some local anaesthetic to numb the area and will inject a small amount of microbubbles into your breast at the edge of the nipple. They will then massage the area to encourage the microbubbles to move into the breast tissue fluid channels. The ultrasound machine will be used to follow the microbubbles to the sentinel lymph node in the armpit. The imaging specialist will use a bit more local anaesthetic in the armpit and then use a needle to take biopsies of the sentinel lymph node. They will also leave a small marker clip to show which lymph node has been biopsied. Your breast unit will then give you advice about what to do and expect after a biopsy procedure. You will also be given a satisfaction questionnaire about the procedure to fill in before you go home.
• You will return to see your doctors about a week after the microbubbles procedure for the results of the sentinel lymph node biopsy. They will also ask you if you had any armpit pain after the microbubbles procedure and check you for any signs of bleeding or infection. This is an extra visit because of the research that wouldn’t be normally needed The results of the sentinel lymph node biopsy will be used to help plan your treatment and together with your doctors, you will decide what type of operation to have in your armpit.
• Your breast and armpit operation will then proceed as normal.
• You will return to see your doctors one to two weeks after the operation for the results, which happens normally. They will ask you if you had any armpit pain after the operation. They will also check your wounds for signs of infection or bleeding. This visit marks the end of your involvement with the study. You will then continue with your breast cancer treatment as decided by you and your doctors.

The microbubble sentinel lymph node biopsy offers you and your doctors more information about whether the armpit lymph nodes contain cancerous deposits. This information could be used to change your treatment plan. For example, some people need chemotherapy as part of their treatment and cancerous deposits found in the sentinel lymph node may mean that you and your doctors decide to change your treatment plan from surgery to chemotherapy first.

You will need to come back to the breast unit for 2 extra visits, the first to have the microbubbles procedure and the second visit to get the results of the sentinel lymph node biopsy.

We will need to use information from your medical records for this research project.

This information will include:

• Your initials and name.
• Your NHS number.
• Your date of birth.
• Your contact details.
• Details about the cancer including the results of the biopsies and surgery.

Staff at your hospital, Maidstone and Tunbridge Wells NHS Trust, Warwick Clinical Trials Unit and regulatory authorities will use this information to do the research or check your records to make sure that the research is being done properly.

We will keep all information about you safe and secure.

You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.

We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.

Where can you find out more about how your information is used?

You can find out more about how we use your information:

• At www.hra.nhs.uk/information-about-patients/
• By asking one of the research team
• Reading the privacy notice
• By contacting the data controller at Maidstone and Tunbridge Wells NHS Trust on 01892 634029.

The study has been organized by specialist doctors involved in diagnosing and treating breast cancer from across the UK as well as the University of Warwick Medical School Clinical Trials Unit and a patient representative. The sponsor of the study is Maidstone and Tunbridge Wells NHS Trust and they will run the study together with Warwick Clinical Trials Unit. The charity Breast Cancer Now has funded the study.

You will be sent a thank you letter and Feedback Forms from Maidstone and Tunbridge Wells NHS Trust. Your feedback is really important and helps us improve the way that we involve patients in medical research.

The results of the study will be presented at Medical Meetings and be published in a Medical Journal. You will also be sent a report of the study (with a link to the medical journal) using words that can be easily understood by people who do not have a background in medicine or science. We will also publish the report on the website of Breast Cancer Now.