We have previously demonstrated that high-frequency ultrasound and spectroscopy, and recently conventional-frequency ultrasound and spectroscopy may be used to detect cell death in vitro, in situ and in vivo. The method can detect different forms of cell death and has been demonstrated to be sensitive to apoptotic, necrotic and mitotic cell death. The objectives of this study are to evaluate the use of ultrasound imaging and spectroscopy as a predictive marker of advanced tumour response to combined chemotherapy and radiotherapy. Since neoadjuvant treatments may also act on tumour vasculature to "normalize" it we will also evaluate blood-vessel imaging by standard Doppler-imaging and with standard higher-resolution imaging using clinically approved microbubble contrast agents.
The main goal, as described above, is to select the best ultrasound spectroscopy parameter to use as an early predictor of pathological complete response.
Histologically or cytologically confirmed breast carcinoma, stage I-IV, 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.
Chemotherapy, radiotherapy, or major surgery within 4 weeks prior to registering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to registration.
Receiving any other investigational agents.
Known brain metastases.
History of allergic reactions attributed to compounds of similar chemical or biologic composition.
Women who are receiving neoadjuvant chemotherapy or neoadjuvant chemo-radiotherapy for breast cancer.
Case-only
Prospective
Not listed
The primary Outcome will be correlate changes in ultrasound backscatter parameters obtained throughout the course of treatment with pathological complete, partial, or complete and partial response.
Ultrasound spectroscopy parameters to be examined include mid-band fit parameters, spectral slope and histogram distribution fit parameters related to scatterer size and concentration. From these various receiver-operator curves, the best ultrasound parameter predictive response will be selected and will aid to define the clinical specificity and sensitivity of The technique.
The secondary Outcome of this study will include examining the change in tumor size.
The change in tumor size, which It will also be measured using conventional gold standard B-scan ultrasound images (length by width by height in addition to volume) and correlating it with spectroscopic ultrasound changes determined at different times during the patient's treatment.
Other secondary Outcome will include measuring changes in the blood vessels distribution in the tumor.
Measurement of changes in the distribution of blood vessels according to the standard doppler-imaging and standard microbubbles contrast agent imaging.
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