A study of a new way to find and remove breast cancer (MOLL Trial)

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 looking at a magnetic marker to help surgeons find and remove breast cancer.

More about this trial

Surgery is one of the usual treatments for breast cancer. You might have a type of surgery called a wide local excision to remove the tumour. This means the surgeon removes the breast tumour and a border of healthy tissue. But this is more difficult when the doctors can’t feel the lump (non palpable tumours). So they insert a wire before surgery to mark where the cancer is.

Researchers have developed a new way to help surgeons find non palpable tumours without using a wire. This includes using a magnetic marker and a small hand held device. This device is called the Tokyo Magnetometer.

In this study, the doctor injects the magnetic marker into the centre of the tumour. They use an ultrasound scan Open a glossary item

to guide them.

The marker is magnetic and can be detected with the Tokyo magnetometer. During surgery, the surgeon uses the Tokyo magnetometer to find the marker and remove the tumour.

The aims of the study are to find out:

how well this new technique works
how acceptable people find it
more about the cost

The study team hope to compare this new technique with the usual way of using a wire to mark the tumour. They hope if this study is successful to test it in a larger group of people.

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

Who can take part

You may be able to join this study if all of the following apply. You:

are due to have surgery for breast cancer
have a tumour that is difficult for the doctors to feel (a non palpable tumour)
have a tumour that doctors can see on an ultrasound scan

Who can’t take part

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

are intolerant to or sensitive to iron or anything it contains
have a pacemaker or any other implantable device in the chest wall

Trial design

The study team hope 40 people will take part, but a first analysis will take place after the first 20 patients have taken part in the study.

To begin with, you go to the radiology department on the day of surgery, or the day before. You will have an injection of local anaesthetic to numb the area. Then the doctor injects the magnetic marker into the tumour using an ultrasound scan to guide them. Then you have your surgery.

During your operation, the surgeon uses the Tokyo magnetometer to find the marker. This tells the surgeon where the centre of the tumour is. The surgeon will remove the tumour and place it in a specimen radiograph. This is to check the surgeon has removed all the cancer.

The surgical team send the specimen to the lab for analysis as they would normally when you have surgery for breast cancer. The study team will tell you how long you stay in hospital after surgery.

After surgery, you go to the breast clinic for a check up:

7 to 14 days later
12 months later

These visits are routine after breast cancer surgery.

Hospital visits

You shouldn’t have any extra visits as a results of taking part in this study.

Side effects

You might have some discomfort when you have the marker injected. But this should only last for a short period of time.

We have information about the possible side effects of breast cancer surgery.

Recruitment start:

21/09/2017

Recruitment end:

31/01/2019

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.

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Questions to ask your doctor about clinical trials

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Prof Michael Douek

Supported by

Association of Breast Surgery
Guy’s and St. Thomas’ Charity
Guy’s and St. Thomas’ Foundation Trust
King’s College London

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Email

Last review date

8 March 2019

CRUK internal database number:

15157