A study looking at a way of finding very small breast cancers and sentinel lymph nodes (MagSNOLL)

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 using a magnetic substance to show up very small tumours in the breast and to find lymph nodes under the arm.

If breast cancer is found through breast screening, it may be too small to be felt as a lump. If so, during an ultrasound scan, your doctor can put a fine wire into the area containing the cancer. A surgeon can then use the wire to find the area where the breast cancer is and remove it. But this method does have some drawbacks. The wire can cause discomfort and some people need to have another operation because not all of the cancer is removed.

It is also important to find out if cancer cells have spread to lymph nodes Open a glossary item under your arm. The first lymph nodes that fluid from the breast reaches are called the sentinel nodes. If breast cancer has spread, these are the lymph nodes most likely to contain cancer cells.

Finding and removing the sentinel lymph nodes is called a sentinel lymph node biopsy. You have a small amount of mildly radioactive liquid (a tracer) and a blue dye injected into your breast. Your surgeon can see when the dye reaches the sentinel nodes. And they use a small radioactive monitor to see when the tracer reaches them. The surgeon removes about 1 to 3 of these nodes and sends them off to the laboratory to see if they contain cancer cells.

Researchers have developed a device called a magnetometer that can detect a magnetic tracer injected into the breast. They know that it is possible to find sentinel lymph nodes using this system. They now want to find out if it is possible to see both the breast cancer and the sentinel nodes with a single injection of the magnetic tracer. If this is possible, it would avoid the need to use a wire before surgery and avoid using a radioactive substance to find the sentinel lymph nodes.

Who can enter

You cannot volunteer to take part in this study. You may be asked to take part if you have breast cancer that can be seen on an ultrasound scan and you are going to have a sentinel lymph node biopsy.

You cannot enter this study if you

  • Are very sensitive to the magnetic tracer or compounds that contain  iron
  • Cannot have the radioactive tracer
  • Have a condition causing you to have too much iron in your body
  • Have a pacemaker

Trial design

This is a feasibility study. To begin with, the study will recruit 10 people with breast cancers that the surgeon can feel during an examination. If the magnetometer successfully shows the breast cancer in all these people, the study will then recruit 40 more people. Some of them will have breast cancer that is too small for the surgeon to feel during an examination.

Everybody taking part in the study has an injection of the magnetic tracer as well as the radioactive tracer.

Sometime during the 24 hours before your surgery, a doctor who specialises in reading scans (a radiologist) will inject the magnetic tracer into the middle of your breast cancer. They will use an ultrasound scanner to help them do this and you have a mammogram afterwards. You will not have a wire put into your breast before surgery.

A couple of hours before your surgery, you have an injection of the radioactive tracer.

You have your surgery as planned. During the operation, your surgeon will use both the magnetometer and the radioactive monitor to find the sentinel lymph nodes and remove them. They will then continue to use the magnetometer to identify the breast cancer before removing it.

They will send the lymph nodes and the breast cancer to the laboratory to be looked at under the microscope. This is part of standard care.

Hospital visits

You see the trial team between 1 and 2 weeks after your surgery and again after a year. They will also ask you to go and see them after 3 months, but this visit is optional.

Side effects

Side effects of the magnetic tracer can include a rash, itching, dizziness or feeling light headed. But these effects are very rare.

If larger amounts of the magnetic tracer are used near to the skin, it can cause temporary marking of the skin. But this should not be a problem with the small amount of tracer being injected into the breast in this study.

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

Prof Michael Douek

Supported by

Endomagnetics Ltd
Experimental Cancer Medicine Centre (ECMC)
Guy's and St Thomas' NHS Foundation Trust
King's College London
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11238

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

Deborah wanted to help other breast cancer patients in the future

A picture of Deborah

“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."

Last reviewed:

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