RECRUITINGOBSERVATIONAL

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

Pilot Investigation of Ultrasound Imaging and Spectroscopy as Early Indicators of Locally- Advanced Breast Cancer Response to Neoadjuvant Treatment

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 1. diagnosed by tissue sample (biopsy-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. expected to live at least 6 months 5. Patients should have the ability to understand and the willingness to sign a written willing to sign a consent form document. Signed willing to sign a consent form must be obtained prior to any study specific procedures Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Locations (3)

MD Anderson

Houston, Texas, United States

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada