A trial looking at the use of the LightPath Imaging System during breast surgery (LPM-007)

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 trial is for women who are due to have an operation called a wide local excision to remove their breast cancer. It is for woman who have invasive breast cancer. Open a glossary item

More about this trial

Surgery is one of the main treatments for early stage breast cancer Open a glossary item. But it can be difficult for a surgeon to know whether they have taken out all of the breast cancer.

The surgeon aims to remove enough tissue so that there is a clear margin (there are no cancer cells) around the cancer. After your operation, an expert called a pathologist Open a glossary item examines the tissue. They check to make sure there is a clear margin.

You might need to have another operation if the pathologist thinks that some cancer has been left behind. At the moment, about 1 in 5 women need to have a second operation to make sure all the breast cancer has been removed.

Doctors want to find out whether a device called the LightPath Imaging System can help breast cancer surgeons decide whether they have removed all of the cancer during surgery.

Before your operation you have an injection of a substance called an imaging agent. This is a sugar substance containing a radioactive molecule that is taken up in active tissues, including many types of cancer.

This imaging agent is normally used during a diagnostic test called a PET scan. It helps to show your doctor where the cancer cells are.

The LightPath Imaging System is able to see where the imaging agent goes in your body. And specifically whether the imaging agent is in the tissue that the surgeon plans to remove from your breast.

LightPath works by detecting the small amount of light produced by the radioactive molecule within the imaging tracer. The surgeon can look at the pictures while they carry out the operation. The areas that are orange coloured or lit up in the pictures are more likely to be cancer.

LightPath-Imaging-System

The aim of this trial is to find out whether the LightPath Imaging System can help surgeons remove all of the breast cancer. The trial team will also collect information about:

  • the number of women who need to have another operation
  • the tissue that is removed
  • the quality of life Open a glossary item of women taking part
  • any women whose cancer comes back after treatment

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.

You may be able to join this trial if:

  • You have invasive breast cancer 
  • Your cancer is only in 1 area and is contained in one quarter (or quadrant) of the breast and there is no cancer in your nipple
  • You are due to have an operation called a wide local excision to remove part of the breast         
  • You are female and 18 years of age or older
  • You have had a negative pregnancy test if it is possible that you could become pregnant. Or you must have had an operation to make you sterile, or you have not had periods in the past twelve months

You cannot join this trial if any of these apply. You

  • Have cancer cells contained within the ducts of the breast (ductal carcinoma in situ) or you have a breast condition called pleomorphic lobular carcinoma in situ (LCIS)
  • Have had surgery to the affected breast in the last 12 months
  • Have had radiotherapy treatment to affected breast
  • Have already had treatment before your breast surgery (neo adjuvant therapy) that reaches the whole body (systemic treatment Open a glossary item)
  • Have had systemic chemotherapy in the last 2 years
  • Are allergic to 18F-FDG, the imaging tracer used in this trial
  • Are due to have a test called a radioguided occult lesion localisation (ROLL) to investigate a suspicious area of the breast that cannot be felt on examination
  • Are pregnant or breastfeeding
  • Have or have had another type of cancer, unless it has been successfully treated
  • Have taken part in another trial in the last 2 months
  • Have any other serious medical condition that the trial team think could affect you taking part

Trial design

The researchers need 170 women to join this European trial.

When this trial first opened to recruitment there were 2 groups. It was a randomised trial and people were put into groups by a computer.  

  • One group had routine care (this was the control group)
  • The other group had routine care as well as LightPath Imaging System during their surgery

Diagram showing trial randomisation

Please note, the control group has now closed to recruitment. Everyone joining this trial will now have routine care as well as LightPath Imaging System.

Just before your operation you have an injection of an imaging tracer called 18F-FDG. You have this injection through a small plastic tube called a cannula Open a glossary item in your arm.

As part of your routine care, you might have your lymph nodes checked with a sentinel lymph node biopsy. If so, you also have an injection containing a different type of radioactive molecule. This is called technetium. As you are having LightPath Imaging, you are given more of this imaging agent than normal. The LightPath device might also be used to look at any lymph nodes removed during your operation. 

Hospital visits

All women will have a pregnancy test if there is a chance you could become pregnant. This is because of a risk that the radiation (from technetium or 18F-FDG) could harm the baby.

Before surgery, you go to hospital to meet with a member of the trial team. This is arranged for a time when you also have a routine appointment. So you don’t have to make an extra visit. The trial team:

  • ask you questions about your health
  • measure your height, weight and bra cup size
  • collect information about your diagnosis and breast cancer

You have some routine tests as part of your preparation for breast surgery. These tests are part of your routine care and not part of this trial. Your doctor or specialist nurse will tell you more about this.

After your operation the trial team will collect information on:

  • your type of surgery
  • the cancer tissue
  • whether you have had any problems after your surgery

You see your surgeon 1 to 6 weeks after your operation. How soon you see them depends on your hospital’s policy. At this meeting they will let you know if you need to have another operation.

Side effects

The risks of your breast cancer surgery include:

  • pain
  • infection
  • bleeding

If you are in the group having the LightPath Imaging System, you are exposed to some extra radiation as a result of having the radioactive tracer. Although high levels of radiation can cause cancer, the amount used in this trial is small.

18F-FDG is used routinely as part of a PET-CT scan to diagnose some types of cancer. In this trial, the same amount of 18F-FDG is used for a routine PET-CT scan.

Technetium is routinely used to carry out a sentinel lymph node biopsy in people with breast cancer. But the amount you have in this trial is higher than the amount used in standard care.

The amount of radiation you are exposed to in this trial is less than the radiation you would have from a CT scan of your chest and tummy. The trial team will explain the risk and benefits and what this means for you.

If you are in group using the LightPath Imaging System, it might mean your surgeon can avoid a second operation but we don’t know this for sure. This is what this trial is trying to find out. 

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 Arnie Purushotham 

Supported by

European Commission
Lightpoint Medical Ltd

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13906

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

A 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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