RecruitingOBSERVATIONAL

Intra-operative Detection of Positive Margins in Breast Surgery

This research is looking at a new device for breast cancer surgery. When surgeons remove a lump, they want to make sure all the cancer is gone. This new device uses special light (called OCT-Raman) to scan the edges of the removed tissue during the operation. It first quickly identifies fatty areas, then focuses on other areas to tell the difference between healthy tissue and cancer cells. This helps surgeons see if any cancer is still at the edges (called 'positive margins'). The goal is to make these checks faster and more accurate, so surgeons can make better decisions during surgery. It's a proof-of-concept study, meaning it's an early test of this new technology.

At a glance

Status

Recruiting

Sponsor

University of Nottingham

Enrolment target

120

Start

01 Oct 2023

Estimated completion

01 Apr 2027

Breast Cancer Invasive

What is this study about?

This study is looking at an exciting new way to help women undergoing surgery for breast cancer. When a surgeon removes a cancerous lump, it's very important to make sure all the cancer cells have been taken out. Sometimes, tiny cancer cells can be left behind at the edges of the removed tissue – these are called 'positive margins'. If this happens, a patient might need more surgery later, which can be distressing.

Researchers have developed a new device that uses two types of light technology, called OCT and Raman. This device will quickly scan the removed breast tissue during the operation. The first part, OCT, helps identify areas that are mostly fat. This is clever because cancer cells are very unlikely to be found in fatty tissue, so the device can then focus its powerful second part, Raman, on the more important areas where cancer might be lurking. This greatly speeds up the process.

The device uses computer 'brains' (called deep learning algorithms) to automatically analyse the scans and show the surgeon if there are any positive margins. This means the surgeon gets information very quickly, while the patient is still in surgery. If successful, this could help more patients have all their cancer removed in one go, potentially reducing the need for follow-up surgeries.

Key takeaways

Tests a new device to find cancer cells at the edges of removed breast tissue during surgery.
Uses light technology (OCT-Raman) to quickly scan tissue samples.
Aims to make breast cancer surgery more accurate, potentially reducing the need for repeat operations.
Your medical care and surgery will not be affected by taking part.
Aims to improve future care for breast cancer patients.

Who may be eligible?

This study is looking for women who are having surgery to remove a breast lump because of breast cancer. It's important that you fully understand what the study involves and are happy to give your permission to take part.

There are no age limits, so women of any age can join if they meet the other requirements. The main thing is that you're already going to have a specific type of breast cancer surgery called a 'wide local excision'.

You wouldn't be able to join if there is any uncertainty about your breast cancer diagnosis, as confirmed by your specialist doctor.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you having surgery for breast cancer?
Is your surgery a 'wide local excision'?
Have you received a clear diagnosis of breast cancer from your doctor?
Are you able to understand and give permission to take part?

Answer every question to see your result.

What does participation involve?

If you choose to take part, the study involves simply scanning your removed breast tissue with a new device after your surgeon has taken it out during your operation. You won't feel anything, and it won't affect your surgery or how your tissue is normally handled afterwards.

The device will quickly examine the surface of the tissue. No extra tissue will be taken, and your surgery will not be changed because of this study. The results from the device in this particular study will not be used to make decisions about *your* care; they are purely for research purposes to see if the device works as intended. After scanning, your tissue will go directly to the pathologists for their usual checks, just as it would normally. There are no extra visits or follow-up appointments required for taking part in this study.

Potential risks and benefits

Taking part in this study does not involve any direct medical risks to you, as the device only scans tissue that has already been removed. It will not change your surgical plan or the care you receive. The results generated will not be used for your immediate treatment decisions. The potential benefit is that this research could help improve future breast cancer surgeries for many women, by making it faster and more accurate to detect any remaining cancer cells during an operation. You are free to change your mind and withdraw from the study at any time, without giving a reason, and without this affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Nottingham university hospitals
Verified postcode
Nottingham, United Kingdom· Recruiting

Common questions

What is the purpose of this study?

The study aims to test a new device that uses light (OCT-Raman) to quickly check if all cancer cells have been removed during breast cancer surgery.

Will this device be used to guide my surgery?

No, not in this study. The results from the device in this trial are just for research and won't affect the decisions your surgeon makes about your care.

What will happen to my tissue sample?

After the device scans it, your tissue sample will go to the pathologist for the usual checks, just as it would if you weren't in the study.

Do I need to do anything extra if I join?

No, you don't need to do anything extra. This study only involves scanning your removed tissue on the day of your surgery.

Is the device safe?

Yes, it's considered safe. It only scans tissue outside your body after it's been removed, so there's no risk to you during the operation.

How to find out more

Ioan Notingher

ppzin@exmail.nottingham.ac.uk 0)115 951 3082 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.