Using ultrasound and spectroscopy to monitor breast cancer treatment response

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the use of ultrasound imaging and spectroscopy to monitor cell death in locally advanced breast cancer patients undergoing neoadjuvant chemotherapy or combined chemo-radiotherapy. The primary goal is to identify ultrasound parameters that can predict early treatment responses, allowing for timely adjustments to therapy if necessary. By detecting treatment efficacy within days rather than weeks, this approach aims to improve patient outcomes and reduce unnecessary side effects. The study also includes an analysis of inter-user variability in data interpretation to ensure consistency in results.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Histologically or cytologically confirmed locally advanced breast carcinoma which has not been treated with any first-line therapy and will be treated with neoadjuvant chemotherapy or neoadjuvant combined chemo-radiotherapy
2. Measurable disease by ultrasound, or MRI performed within 28 days prior to treatment
3. Eastern Co-operative Oncology Group (ECOG) Performance Status of 0 or 1
4. Life expectancy of at least 6 months
5. Patients should have the ability to understand and the willingness to sign a written informed consent document. Signed informed consent must be obtained prior to any study specific procedures

Exclusion Criteria:

1. History of allergic reactions attributed to compounds of similar chemical or biologic composition
2. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and cardiac arrhythmia
3. Psychiatric illness/social situations that would limit compliance with study requirements
4. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.

Where it's running

• Sunnybrook Health Sciences Centre
  Toronto, Ontario, Canada Recruiting
• MD Anderson
  Houston, Texas, United States Completed
• Princess Margaret Cancer Centre
  Toronto, Ontario, Canada Completed

Study contacts

• Principal investigator: Gregory Czarnota, PhD, MD — Sunnybrook Health Sciences Centre
• Study coordinator: Gregory J Czarnota, PhD, MD
• Email: gregory.czarnota@sunnybrook.ca
• Phone: (416) 480-6128

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.