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Not yet recruitingOBSERVATIONAL

Three-Dimensional Ultrasound and Spectroscopy as Early Indicators of Breast Cancer Response to Neoadjuvant Treatment

This study is looking for new ways to tell early on if breast cancer treatment is successful. It focuses on women with breast cancer who are receiving chemotherapy or a combination of chemotherapy and radiotherapy before surgery. Researchers will use special 3D ultrasound scans and a technique called spectroscopy to monitor how the cancer cells are reacting to the treatment. The main aim is to find specific measurements from these scans that can predict if a tumour will shrink a lot or disappear completely. Ultimately, this research hopes to help doctors understand sooner which treatments are most effective for individual patients, potentially leading to more personalised and successful care.

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 is all about finding new ways to check if breast cancer treatment is working well, and to see if we can do this earlier than current methods. When someone has breast cancer, they sometimes get treatment like chemotherapy or a combination of chemotherapy and radiotherapy before having an operation. This is called 'neoadjuvant treatment' and it aims to shrink the tumour.

Researchers in this study are using special types of scans that involve 3D ultrasound and something called 'spectroscopy'. Think of spectroscopy as a way to get more detailed information about the tissues and cells than a regular ultrasound. The idea is to see if these advanced scanning methods can show changes in the cancer cells and tumour size at different points during treatment.

The main goal is to identify specific patterns or measurements from these scans that can tell us early on if the tumour is shrinking or even disappearing completely. If successful, this could mean doctors would know sooner whether a particular treatment approach is effective for a patient. This kind of early information could help guide treatment decisions, potentially making care more effective and tailored to each person.

Key takeaways

  • Researchers are using special 3D ultrasound and spectroscopy to monitor breast cancer.
  • The goal is to find early signs that chemotherapy or radiotherapy is working.
  • This could help doctors tailor treatment for future patients.
  • Participation means having extra scans during your normal treatment.
  • The study doesn't involve new medications, only new ways of watching tumour response.

Who may be eligible?

To join this study, you would need to have breast cancer that has been confirmed by a biopsy. Your cancer should not have been treated with chemotherapy or radiotherapy before, and you should be planning to have either chemotherapy or a mix of chemotherapy and radiotherapy as your first treatment.

Your tumour must be visible and measurable with an ultrasound scan. You also need to be generally well enough to take part, meaning you can carry out most daily activities, and your blood tests for things like blood cells and how your liver and kidneys are working need to be within a healthy range. You'd also need to be able to understand and sign a consent form, which explains everything about the study.

There are also some reasons why you might not be able to join. For example, if you’ve recently had chemotherapy, radiotherapy, or major surgery, or if you are taking part in another experimental drug study. Certain other health conditions, like known cancer spread to the brain, severe infections, or some conditions that might make radiotherapy risky, would also mean you couldn't participate. Allergies to similar medications or a history of radiation to the same area would also prevent you from joining.

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. Do I have breast cancer confirmed by a biopsy?
  2. Am I planning to start chemotherapy or combined chemo-radiotherapy as my first treatment?
  3. Is my tumour measurable with an ultrasound scan?
  4. Am I generally well enough to do most daily activities, and are my blood tests generally healthy?
  5. Have I not recently had chemotherapy, radiotherapy, or major surgery?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will continue with your planned breast cancer treatment, which will be either chemotherapy or a combination of chemotherapy and radiotherapy. The main difference is that you will have extra ultrasound scans and spectroscopy at specific times during your treatment. These scans are designed to monitor how your tumour is responding to the treatment.

The study will involve regular follow-up appointments where these scans will be performed. The exact number of visits and the total duration aren't specified but will align with your treatment schedule. There are no new medications given as part of this study; it's purely observational, using the scans to gather more information about your existing treatment.

Potential risks and benefits

Participating in this study might offer the benefit of having your treatment response monitored in a more advanced way, potentially helping future patients receive more personalised care. However, there are no direct health benefits to you personally from taking part. The main risks involve the time commitment for extra scan appointments and any minor discomfort associated with ultrasound scans, which are generally very safe. You have the right to withdraw from the study at any time, for any reason, without it affecting your standard medical care.

Locations (1)

  • Sunnybrook Health Sciences Centre
    Verified postcode
    Toronto, Canada

Common questions

What is 'neoadjuvant treatment'?

It's treatment like chemotherapy or radiotherapy given before surgery to shrink a tumour first.

What is spectroscopy?

It's a special technique used with ultrasound to get more detailed information about the tissues and cells.

Will I get different cancer treatment if I join?

No, you will receive your standard breast cancer treatment as planned; this study just adds extra scans.

How long will I be in the study?

The study will involve extra scans at different points during your regular cancer treatment schedule.

Is ultrasound safe?

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

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 and Spectroscopy as Early Indic…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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