The purpose of the study is to test the hypothesis that ultrasound imaging and spectroscopy may be used as a predictive marker of advanced tumour response to neoadjuvant treatment consisting of chemotherapy or concurrent chemotherapy-radiotherapy. The main goal is to select the best ultrasound spectroscopy parameter and vascular-distribution index to use as an early predictor of pathological complete or partial response as a primary endpoint and tumour size decrease as a secondary endpoint.
This project is an early validation study in human subjects that will use three-dimensional ultrasound imaging and spectroscopy to monitor cell death occurring at various time points during a patient's treatment for advanced breast cancer. Standard neoadjuvant treatments for breast cancer consisting of combined chemotherapy and radiotherapy will be used in patients. Reponses will be followed with ultrasound imaging and spectroscopy at regular predetermined time-points. The research is exploratory since upon data analysis it will examine the use of different ultrasound backscatter parameters as potential markers of cell death and correlate these with changes in tumour size and complete pathological response.
Study Type
OBSERVATIONAL
Enrollment
200
Ultrasound imaging and spectroscopy will consist of collecting three dimensional data. Regions of interest in each of the tumour images and in the adjacent normal tissue will be selected for analysis.
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Ultrasound imaging and spectroscopy as a predictive marker of early predictor of complete pathological response.
The primary endpoint of this study will be to correlate changes in ultrasound backscatter parameters obtained throughout the course of treatment with complete or partial pathological response.
Time frame: Up to 5 years
To Examine the change in tumour size over the course of treatment and correlating it to changes in ultrasound backscatter parameters.
Tumour size will be measured using conventional B-mode ultrasound imaging. Both the tumour's maximum dimensions length, width, and height in cm will be considered.
Time frame: Up to 5 years
To Examine the change in tumour Volumen over the course of treatment and correlating it to changes in ultrasound backscatter parameters.
The Volumen of the tumor will be measured by conventional ultrasound in B mode. The volume of the tumor in cm3 will be considered.
Time frame: Up to 5 years
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