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Not yet recruitingOBSERVATIONAL

Three-Dimensional Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses

This study is looking into new ways to use ultrasound, a type of scan, to understand breast lumps better. The goal is to see if these advanced ultrasound techniques can help doctors work out if a lump is cancer or not, simply by looking at the scan images. By finding specific patterns or 'signatures' on these special ultrasounds, the researchers hope to develop a less invasive way to assess breast changes. This could mean more accurate diagnoses and potentially fewer uncomfortable tests for patients in the future. The study will compare these new ultrasound findings with information gathered from biopsies or surgery to check how accurate they are, and will also look at how patients do in the long term.

At a glance

Status
Not yet recruiting
Sponsor
Sunnybrook Health Sciences Centre
Enrolment target
200
Start
01 Apr 2024
Estimated completion
01 Apr 2029

What is this study about?

This study focuses on improving how we understand breast lumps using a type of scan called ultrasound. You might have had an ultrasound before, which uses sound waves to create pictures inside your body. Here, scientists are using a more advanced version of ultrasound, along with a technique called spectroscopy, to get a much more detailed look at breast tissue.

The main idea is to see if these special ultrasound scans can give doctors enough information to tell if a breast lump is cancerous or not, without always needing to take a sample (a biopsy) or perform surgery. They're trying to find specific patterns or characteristics within the ultrasound images that reliably point to whether a lump is harmless or needs further treatment. For example, imagine you have a bruise; a regular picture shows it's blue, but a special camera might reveal how deep it is or how much blood flow is there. This is similar, but for breast lumps.

To do this, they will compare what the new ultrasound scans show with what doctors already know from standard tests, like biopsies or surgery reports. They also want to see if the information from these scans can help predict how people will fare over time, looking at their health after two and five years. Ultimately, this research aims to make diagnosing breast lumps clearer and potentially less invasive for patients in the future.

Key takeaways

  • Uses special ultrasound scans to look at breast lumps.
  • Aims to find better ways to tell if a lump is cancerous without biopsies.
  • No new medicines or treatments involved.
  • Compares new ultrasound findings with existing medical records.
  • Helps improve future diagnostic methods for breast cancer.

Who may be eligible?

This study is open to both women and men who have been told they have a suspected breast lump or possible breast cancer. An important part of joining is that you need to be able to understand the study details and be willing to sign a consent form, showing you agree to take part.

However, there are some reasons why someone might not be able to join. For example, if you've recently had chemotherapy, radiotherapy, or major surgery within the last month (four weeks), or if you're still recovering from any treatments, you wouldn't be able to participate. This is to make sure your health is stable during the study.

Also, if you're already trying other experimental medicines or treatments, or if you have any health problems that could make it unsafe for you to be in the study or make it difficult to follow the study plan, then you would not be able to take part. The research team needs to make sure the study is safe and right for everyone involved.

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.

  1. Are you a man or woman with a suspected breast lump or cancer?
  2. Can you understand the study information and agree to take part?
  3. Have you avoided chemotherapy, radiotherapy, or major surgery in the last 4 weeks?
  4. Are you not currently on other experimental medicines?
  5. Are you generally well enough to take part and follow procedures?
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 advanced ultrasound scan of your breast. This is similar to a regular ultrasound but will use additional techniques to gather more detailed information about your breast lump. There are no medications or special interventions given as part of this study itself, as it's purely observational. The researchers will simply collect the ultrasound images and then compare the findings from these images with the results from any other standard tests you've had, such as biopsies or surgery reports. The main part of your involvement will be this ultrasound scan, and then the researchers will use your existing medical information (like biopsy results) to see how well the new ultrasound technique works. There's no specific follow-up required by the study, as they will look at your general health outcomes over two and five years using your medical records.

Potential risks and benefits

Taking part in this study involves very few direct risks, as the main activity is an ultrasound scan, which is a safe, non-invasive procedure commonly used in healthcare. The potential benefit is that your participation helps researchers learn more about breast lumps, which could lead to better and less invasive diagnostic methods for everyone in the future. There are no direct benefits to you as an individual from this study, as this is purely research focused on improving future care. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care in any way.

Locations (1)

  • Sunnybrook Health Sciences Centre
    Verified postcode
    Toronto, Canada

Common questions

What is an 'advanced ultrasound'?

It's like a regular ultrasound but uses extra techniques to gather more detailed information about breast tissue, helping to look closely at breast lumps.

Will I get any medicine as part of this study?

No, this study doesn't involve any new medicines or treatments. It's about using and analysing special ultrasound scans.

Why are they doing this study?

The goal is to find better, less invasive ways to understand breast lumps and tell if they are cancerous, potentially reducing the need for biopsies in the future.

How long will I be involved in the study?

Your main involvement will be attending for the ultrasound scan. The researchers will then look at your existing medical records for long-term information.

Will I find out the results of my special ultrasound?

The study collects information for research purposes. Any findings relevant to your care would be discussed with your doctor as part of your standard medical management.

How to find out more

Gregory J Czarnota, PhD, MD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Three-Dimensional Ultrasound Imaging and Spectroscopy for Ch…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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