Three-Dimensional Ultrasound Imaging and Spectroscopy for Characterizing Breast Masses

Condition(s) studied

Investigational drug(s) / intervention(s)

Ultrasound Imaging 3D and Spectroscopy: 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.

Study summary

The purpose of the study is to test the hypothesis that quantitative ultrasound techniques including spectroscopy may be used as a non-invasive biomarker for characterization of suspected breast cancers. The main goal is to select and identify an optimal set of quantitative ultrasound parameters that can be used, non-invasively, to characterize suspected breast cancers, as identified based on the histopathology reports on core biopsy specimens, surgery reports, or radiology reports. Primary endpoint will correlate quantitative ultrasound parameters to the histopathological properties, as determined from pathology reports on core biopsy specimens, surgery reports, or radiology reports. The secondary endpoint in this study will include correlating the results of ultrasound-based breast cancer characterization with 2 and 5-years clinical outcomes.

Eligibility

Primary outcome measure(s)

• Correlation of quantitative ultrasound parameters to the histopathological properties of suspected breast cancer tissues. — Up to 2 years
  As a primary endpoint, correlate changes in ultrasound backscatter parameters obtained using spectroscopic techniques, in conjunction with textural analysis on generated parametric images, to the histopathological characteristics from pathology reports on core biopsy specimens, surgery reports, or radiology reports.

Trial sites (1)

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