Ultrasound Imaging and Spectroscopy as Early Indicators of Locally-Advanced Breast Cancer Response
Recruiting · NCT04134780 · Observational (researchers observe without assigning treatment) · Lead sponsor: Sunnybrook Health Sciences Centre
View the official record on ClinicalTrials.gov →What this trial 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 take part
Inclusion criteria
- 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
Exclusion criteria
- 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 it is running
3 locations listed across 1 US state.
- MD Anderson - Houston, Texas, United States
- Sunnybrook Health Sciences Centre - Toronto, Ontario, Canada
- Princess Margaret Cancer Centre - Toronto, Ontario, Canada