RecruitingOBSERVATIONAL

Investigation of Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses

This study aims to discover better ways to use ultrasound scans to understand breast lumps without invasive procedures like biopsies. Breast cancer is very common, and doctors need accurate ways to diagnose and plan treatment. Currently, biopsies are the main way to confirm if a lump is cancerous, but they can have complications and sometimes need to be repeated. Existing imaging like X-rays and standard ultrasound don't give enough detailed information about tissue. This research hopes to find the best measurements from special ultrasound techniques that can quickly and accurately tell doctors more about breast lumps, helping with diagnosis and treatment planning in a kinder way.

At a glance

Status

Recruiting

Sponsor

Sunnybrook Health Sciences Centre

Enrolment target

1,200

Start

23 Sep 2014

Estimated completion

01 Sep 2029

Breast Cancer

What is this study about?

This research study is about finding better and less invasive ways to understand breast lumps. Currently, when doctors suspect a breast lump might be cancer, they often need to perform a biopsy. This is a procedure where a small piece of tissue is removed with a needle and checked under a microscope. While very effective, biopsies can sometimes be uncomfortable, lead to complications, or occasionally need to be redone if the first sample isn't quite right.

Doctors already use ultrasound scans for breast examinations, but this study explores more advanced ultrasound techniques. The goal is to identify specific measurements from these special ultrasounds that can reliably tell doctors more about a breast lump, such as whether it's likely to be harmless or cancerous, without needing to take a tissue sample. Think of it like getting a more detailed picture and understanding of the lump from the outside.

By comparing these new ultrasound measurements with information from existing biopsy results, surgery reports, or previous scans, the researchers hope to figure out which ultrasound readings are most accurate. If successful, this could lead to a new method that gives doctors quicker and more detailed information about breast lumps, making diagnosis easier and potentially reducing the need for some biopsies, ultimately improving care for people with breast concerns.

Key takeaways

New ultrasound methods are being tested for breast lumps.
The aim is to reduce the need for invasive biopsies.
The study only involves advanced imaging, no new treatments.
Both men and women with suspected breast lumps can potentially join.
Your participation helps develop future diagnostic tools.

Who may be eligible?

This study is looking for both women and men who have a breast lump that doctors suspect might be cancer. To join, you need to understand what the study involves and be happy to sign a consent form, which explains everything in detail.

There are some reasons why you might not be able to take part. For example, if you've recently had chemotherapy, radiotherapy, or major surgery within the last four weeks, or if you're still recovering from treatments you had more than four weeks ago. Also, if you're already trying other experimental medicines or treatments, or if you have any other health conditions that might make it unsafe for you to participate or make it hard for you to follow the study's plan, you 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.

Do I have a breast lump that doctors suspect might be cancer?
Have I had chemotherapy, radiotherapy, or major surgery in the last 4 weeks?
Am I currently receiving any experimental medicines?
Am I well enough to safely follow the study instructions?
Can I understand and agree to the study details?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have a special ultrasound scan of your breast. This scan will collect detailed information about your breast lump using advanced techniques. The study doesn't involve any new medicines or treatments; it's purely about using imaging. The information gathered from your scan will then be compared with your existing medical records, such as biopsy results or other reports that your doctor already has. The researchers will use these comparisons to understand if the new ultrasound methods can accurately describe your breast lump. There are no follow-up visits specifically for this study beyond the initial scan, as it's an observational study.

Potential risks and benefits

Taking part in this study might offer a small potential benefit in that you would receive an advanced ultrasound scan, which could provide additional imaging information about your breast lump. However, the main benefit is for future patients, as your participation helps researchers develop better, less invasive ways to diagnose breast conditions. The risks are generally low, as ultrasound is a safe procedure with no known harmful side effects. You will not be given any experimental treatments. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Sunnybrook Health Sciences Centre
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is the main goal of this study?

The goal is to find better ways to use ultrasound to understand breast lumps without needing biopsies.

Will I receive a special treatment if I join?

No, this study only involves an advanced ultrasound scan, not new treatments or medications.

Is the ultrasound procedure safe?

Yes, ultrasound scans are considered very safe and do not use radiation.

How long will I be involved in the study?

Your involvement will mainly be for the time it takes to complete the special ultrasound scan.

Who can take part in this study?

Men and women with a suspected breast lump who can understand and agree to the study details can take part, with some exclusions.

How to find out more

Gregory J Czarnota, PhD, MD

gregory.czarnota@sunnybrook.ca (416)480-6128 Official trial record

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