A study testing a device to check for remaining cancer cells during surgery for early breast cancer

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:

Phase 1

This study is seeing how well a device called terahertz pulsed imaging (TPI) works to show cancer cells during surgery to remove breast cancer, or during a test looking at the lymph nodes Open a glossary item under your arm (a sentinel node biopsy).

If you have early stage breast cancer Open a glossary item, you may have surgery to remove just the area of cancer. This is called a wide local excision or lumpectomy. Your surgeon will aim to completely remove your cancer, along with about 1 cm of normal tissue surrounding it. They then send all this to the pathologist Open a glossary item to check that there are no cancer cells in the surrounding tissue – this is called a clear margin.

If the results show that there are cancer cells in the margin, you have further surgery to remove more tissue. But you may have to wait for these results to come back.

Researchers are looking at a device called terahertz pulsed imaging (TPI) to see if it can test the margin during surgery. TPI uses a harmless type of radiation to find cancer cells in a piece of tissue. In the laboratory, TPI successfully showed the difference between normal breast tissue and cancer cells. In this study, the researchers want to see how well TPI works during surgery. The aim of this study is to compare the results from TPI with what the pathologist finds when the tissue is tested afterwards.

Who can enter

You may be able to enter this study if you are a woman with breast cancer and are having treatment at Guy’s and St Thomas’ Breast Unit in London. If you are suitable, a member of the study team will ask if you would like to take part. Women taking part will be due to have one of the following procedures

  • Surgery to remove just the area of cancer from the breast (wide local excision)
  • Further surgery after a wide local excision because tests on the tissue removed show there may still be some cancer cells left behind (this is called re excision surgery)
  • Sentinel lymph node Open a glossary item biopsy

You must also be between 18 and 90 years old.

You cannot enter this study if you

  • Would not be willing to have more tissue removed during your surgery if TPI showed that there may be cancer cells left behind
  • Are taking part in another clinical trial that may affect the results of this study

Trial design

This study will recruit 50 women. Everybody taking part will have the breast surgery or biopsy already planned for them. The surgeon will use the TPI probe to scan your breast tissue or lymph nodes.

If you are having a wide local excision, the surgeon will remove the cancer and then scan the inside surface from where the cancer was removed. They will also scan the surface of the tissue they remove.

If you are having re excision surgery, the surgeon will scan the tissue that is known to still contain cancer cells. They then remove it and scan the inside surface from where it is removed.

If any scan shows that there are still cancer cells left behind, the surgeon will remove more tissue and then do another scan. They will keep doing this (up to a total depth of 1cm) until the scan stops showing cancer cells in the remaining tissue.

If you are having a sentinel lymph node biopsy, the surgeon will scan the lymph nodes that are removed.

The tissue is sent to the laboratory to be checked in the usual way. The study team can compare these results with the readings from the TPI scan.

Hospital visits

There are no extra hospital visits, but if you are having a wide local excision or re excision, your surgery may take a little longer.

Side effects

If you agree to join this study, you are giving the team permission to remove up to 1cm of breast tissue if TPI appears to detect cancer cells. There is a risk that the test may give a false positive reading, which would mean that you have this breast tissue removed without needing to.

But if this procedure leads to the remaining cancer cells being successfully removed, you should not need to come back for another operation.

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

Professor A Purushotham

Supported by

Engineering and Physical Sciences Research Council (EPSRC)
Experimental Cancer Medicine Centre (ECMC)
Guy's and St Thomas' NHS Foundation Trust
Kings College Hospital NHS Foundation Trust
Technology Strategy Board
TeraView

Freephone 0808 800 4040

Last review date

CRUK internal database number:

5952

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

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:

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