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

Recruiting now

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT04134780

Run by

Sunnybrook Health Sciences Centre

People needed

150

Starts

2014-08-01

Expected to finish

2029-10-01

Last updated by the study team

2023-12-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

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

Full record on ClinicalTrials.gov

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