A trial looking at the use of flexible autoradiography during breast surgery (LPM-007)

Cancer type:

Breast cancer

Status:

Results

Phase:

Other

This trial looked at an imaging technique to help surgeons make sure they remove all of the cancer during surgery. It was for women who were due to have an operation to remove invasive breast cancer. 

This trial was open for people to join between 2018 and 2019. The team published the results in 2021.

More about this trial

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

Surgeons aim to remove the cancer, and an area of healthy tissue around it. This is called the margin. Specialist doctors look at the cells removed from the margin after the operation. This is to make sure it doesn’t contain any cancer cells. 

The surgeon may want to do another operation if there are cancer cells in the margin. This is to make sure all of the cancer is removed. When this trial was done, about 1 in 5 women needed to have a second operation.

In this trial they looked at an imaging technique called flexible autoradiography (FAR). This was done using a device called the LightPath Imaging System. 


People taking part had an injection of an imaging tracer before their operation. This tracer is taken up by cancer cells and shows up on a scan.

The surgeon can look at the scan pictures during the operation. Any areas lit up in the pictures are more likely to be cancer.

The main aim of this trial was to find out whether FAR can help surgeons be sure they have removed all of the breast cancer. 

Summary of results

Trial design
This trial was for women due to have a wide local excision to remove early stage breast cancer

They had an injection of an imaging tracer called 18F-FDG before their operation. The surgeons looked at the flexible autoradiography (FAR) images taken during surgery. And specialist doctors looked at the cells in the lab after the operation.

Results
The research team looked at how many margins contained cancer cells. They looked at a total of 385 margins from 66 women. 

They compared the analysis by a specialist doctor with the results from the FAR images.

First they looked at how many margins did contain cancer cells. The results showed that:

  • specialist doctors found cancer cells in 13 margins
  • the FAR images showed up cancer cells in 6 of these margins

This means there were 7 false negative results (53.8%) using FAR.

Then they looked at how many margins didn’t contain cancer cells. The results showed that:

  • specialist doctors found no cancer cells in 372 margins
  • the FAR images showed there were no cancer cells in 304 of these margins

This means there were 68 false positive results (18%) using FAR.

Conclusion
The trial team concluded that FAR was safe and could detect cancer cells in the margins of some people. But that improvements need to be made to make it more accurate.

More detailed information
There is more information about this research in the reference below. 

Please note, this article may not be in plain English. It has been written for health care professionals and researchers.

Intraoperative [18F]FDG flexible autoradiography for tumour margin assessment in breast-conserving surgery: a first-in-human multicentre feasibility study
P Jurrius and others
European Journal of Nuclear Medicine and Molecular Imaging Research (EJNMMI Research), 2021. Volume 11, Article 28.

Where this information comes from    
We have based this summary on the information in the article above. This has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.
 

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

Dr n.med. Maria Turska-d’Amico

Supported by

European Commission
Lightpoint Medical Ltd
Maria Skłodowska‑Curie Institute of Oncology
King’s College London

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.

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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