RecruitingNAINTERVENTIONAL

Positron Emission Mammography and Liquid Biopsy in Women With High-risk Breast Screenings

This research wants to find out if two new tests can help doctors better detect breast changes in women who are at a higher risk of breast cancer. The first is called a 'Liquid Biopsy', which is a blood test that can find very early signs of cancer. The second is an imaging scan called 'Positron Emission Mammography' (PEM), which uses a small amount of a special dye to create detailed pictures of the breast. By seeing if these tests, alone or together, can give clearer information, doctors hope to reduce the number of unnecessary biopsies for women, which can cause worry. Taking part means having a blood test and a PEM scan before a planned MRI-guided biopsy.

At a glance

Status

Recruiting

Phase

Sponsor

University Health Network, Toronto

Enrolment target

100

Start

21 Sep 2023

Estimated completion

31 Jul 2027

Breast Cancer

What is this study about?

This study is investigating two potentially new tests for women who are at a higher risk of developing breast cancer and have had some concerning findings on their usual breast screenings. The main goal is to see if these new tests can help doctors get a clearer picture of what's happening in the breast and decide if further actions, like a biopsy, are truly needed. If these tests prove to be accurate, they could eventually help many women avoid unnecessary procedures and the anxiety that comes with them.

The first test is called a 'Liquid Biopsy.' This is a simple blood test that can look for tiny clues in your blood that might indicate the presence of very early cancer cells. The second test is 'Positron Emission Mammography' (PEM). This is a special type of scan, a bit like an extra detailed mammogram, which uses a very small amount of a safe, temporary dye injected into your body. This dye helps a special camera to highlight any potential breast tumours with high precision.

We want to discover if using these tests, either separately or alongside each other, can give clearer information to your doctors. This could help them better understand any breast changes that have been found. If they are successful, these methods could become new ways to diagnose breast changes, helping doctors make more confident decisions and potentially reducing the need for biopsies that turn out to be unnecessary, especially for women who are already worried about their breast health.

Key takeaways

This study evaluates new tests (Liquid Biopsy, PEM) for breast cancer in high-risk women.
Aims to help doctors see breast abnormalities more clearly.
Could help reduce unnecessary biopsies and anxiety.
Participation involves a blood test and a special scan (PEM) before a planned biopsy.
You must be over 18 and already scheduled for an MRI-guided biopsy.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must also be planning to have a special type of breast biopsy called an MRI-guided biopsy because your standard breast screenings have shown something concerning. It's very important that you understand what the study involves and are happy to give your written permission to take part.

There are some reasons why you wouldn't be able to join. For example, if your standard mammograms or MRI scans don't show any suspicious areas, this study isn't for you. Also, if you are pregnant, think you might be pregnant, or are breastfeeding, you cannot participate. Finally, if you have any known allergies to the special dye (called F-18 FDG) used in the PEM scan, you also wouldn't be able to join.

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 18 years old or older?
Are you scheduled for an MRI-guided biopsy for a suspicious breast finding?
Are you NOT pregnant or breastfeeding?
Do you NOT have an allergy to the F-18 FDG dye?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have a blood test for the Liquid Biopsy. After that, you will have a PEM scan, which involves a small injection of a safe, temporary dye and then a special scan of your breasts. All of this will happen before you have your planned MRI-guided biopsy for the suspicious area in your breast. There aren't any extra follow-up visits or medications required as part of the study; it focuses on these specific tests before your scheduled procedure. The total duration of your active participation would be during the appointments for the blood test, PEM scan, and your regular MRI-guided biopsy.

Potential risks and benefits

Taking part in this study might offer the benefit of contributing to new knowledge that could improve breast cancer detection for other women in the future, potentially reducing anxiety and unnecessary procedures. While the Liquid Biopsy is a standard blood draw with very low risk, the PEM scan involves a small amount of radiation from the injected dye, similar to other medical imaging procedures like X-rays, which carries a very small theoretical risk. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University Health Network
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is a 'Liquid Biopsy'?

It's a simple blood test that looks for tiny pieces of information in your blood that could suggest very early signs of cancer.

What is 'PEM'?

PEM stands for Positron Emission Mammography. It's a special high-resolution scan that uses a small amount of a safe, temporary dye to help doctors see detailed pictures of your breast tissue.

Will these tests replace my regular mammogram or MRI?

No, this study is looking at these tests as new tools to potentially help doctors, but they are not currently a replacement for your standard mammogram or MRI.

What does 'high-risk breast screening' mean?

It means your regular breast checks have shown something that doctors want to investigate further, making you a good candidate for this research.

Will I get results from the Liquid Biopsy or PEM immediately?

You won't get immediate results from these study tests. The purpose of the study is to evaluate their accuracy and usefulness over time.

How to find out more

Samira Taeb, MSc

samira.taeb2@uhn.ca 416-946-4501 Official trial record

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