“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."
A trial looking at a new device to help surgeons know if they have removed all the breast cancer (REI-EXCISE)
This trial is looking at a device called the intelligent Knife or iKnife. They want to find out if it can help surgeons know if they have removed all of the cancer, during breast cancer surgery.
It is for people who are going to have surgery to remove an area of cancer from the breast. This is often called:
- wide local excision
- breast conserving surgery
Cancer Research UK supports this trial.
More about this trial
After the operation, a
The risk of the cancer coming back is lower if you have clear margins after surgery. So, you might need more surgery to take more tissue away if there are positive margins after lumpectomy.
Surgeons would like to know during surgery if they have removed all of the cancer and the margins are clear. So that it reduces the need for another operation. In this trial, they are looking at a new device called intelligent knife (iKnife).
The iKnife works in the same way as the standard surgical tools. But it catches the substances produced during surgery (smoke) and passes it through a machine. The machine then tells the surgeon if they are removing healthy or cancer tissue.
The aim of this trial is to find out if surgeons can use the iKnife during surgery to check that they have removed all of the cancer.
Who can enter
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial 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 trial if all of the following apply. You:
- have ductal carcinoma in situ (DCIS), invasive ductal carcinoma or invasive lobular carcinoma
- are going to have a lumpectomy
- are at least 18 years old
Who can’t take part
You cannot join this trial if any of these apply. You:
Researchers need about 175 people to take part.
You have surgery on the same way as you would if you weren’t taking part in this trial. Your doctor can tell you what happens during the operation.
During surgery, doctors use the iKnife to analyse the substances produced (smoke). They then compare these results with the pathologist report.
The surgical team makes a video during the operation. This is so doctors know which part of the breast they removed when they look at the iKnife results. Only members of the research team will look at the video. And no one will be able to identify you.
You see a doctor before the operation. They look at your
You have surgery as planned. Doctors send any cancer and healthy tissue removed to the pathologist. This is the same as the standard treatment.
After a lumpectomy, you usually go home the same day, or occasionally the day after surgery. The trial team doesn’t think you need to stay in hospital any longer than normal, if you take part in this trial.
About 2 out of every 10 people (20%) need more surgery afterwards. Your doctor might ask you to continue in this trial if this happens.
How to join a clinical trial
Professor Zoltan Takats
Mr Daniel Richard Leff
Cancer Research UK
Imperial College Healthcare NHS Trust
Imperial Clinical Trials Unit - Cancer (ICTU-Ca)
This is Cancer Research UK trial number CRUK/16/021