Ultrasound Imaging and Spectroscopy as Early Indicators of Locally-Advanced Breast Cancer Response

What this study is about

This work explores the possibility of using ultrasound imaging and spectroscopy as a way of monitoring cell death, hence, tumour response to treatment. The hypothesis here is that it can be used as a way of monitoring early response to cancer treatment and predicting which patients continue on in their therapy to have a complete pathological response as a primary endpoint and tumour size decrease as a secondary endpoint. If this work is successful it could be used in the future early on in a cancer patient's treatment to predict whether or not a course of chemotherapy or radiotherapy is going to be successful. For example, in patients in which the analysis indicates a poor response the chemotherapy regimen could be changed to a more efficacious one or for those receiving radiotherapy predicted to have a poor response a radiosensitizing agent could be used to improve outcome.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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
• Measurable disease by ultrasound, or MRI performed within 28 days prior to treatment
• Eastern Co-operative Oncology Group (ECOG) Performance Status of 0 or 1
• Life expectancy of at least 6 months
• 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

🚫 You may not be able to join if…

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

Where this trial is running

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

Who to contact

Gregory J Czarnota, PhD, MD · (416) 480-6128 · gregory.czarnota@sunnybrook.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT04134780.