Computerized Ultrasound Risk Evaluation (CURE) System: Development of Combined Transmission and Reflection Ultrasound with New Reconstruction Algorithms for Breast Imaging

Our Computerized Ultrasound Risk Evaluation (CURE) system has been developed to the engineering prototype stage and generated unique data sets of both transmission and reflection ultrasound (US). This paper will help define the clinical underpinnings of the developmental process and interpret the imaging results from a similar perspective. The CURE project was designed to incorporate numerous diagnostic parameters to improve upon two major areas of early breast cancer detection. CURE may provide improved tissue characterization of breast masses and reliable detection of abnormal microcalcifications found in some breast cancers and ductal carcinoma in situ (DCIS). Current breast US is limited to mass evaluation, whereas mammography also detects and guides biopsy of malignant calcifications. Screening with CURE remains a distant goal, but improved follow-up of mammographic abnormalities may represent a feasible breakthrough. Improved tissue characterization could result in reduction of the estimated one million benign biopsies each year in the United States, costing up to several billion dollars. Most breast calcifications are benign and comprise-80% of stereotactic biopsies guided by mammography. Ultrasound has the capability of finding some groups of calcifications, but further improvements in resolution should also address tissue characterization to define the soft tissue filling of ducts by DCIS. In this manner, CURE may be able to more accurately identify the malignant calcifications associated with progression of DCIS or early cancers. Currently, high-resolution US images of the breast are performed in the reflection mode at higher frequencies, which also limits depth of penetration. Reconstruction of reflection ultrasound images relies upon acoustic impedance differences in the tissue and includes only direct backscatter of the ultrasound signal. Resolution and tissue contrast of current US continues to improve with denser transducer arrays and image processing, but the operator dependent nature of using a moveable transducer head remains a significant problem for thorough coverage of the entire breast. We have therefore undertaken the development of a whole breast (i.e., including auxiliary tail) system, with improved resolution and tissue characterization abilities. The extensive ultrasound physics considerations, engineering, materials process development and subsequent algorithm reconstruction are beyond the scope of this initial paper. The proprietary nature of these processes will be forthcoming as the intellectual property is fully secured. We will focus here on the imaging outcomes as they apply to eventual expansion into clinical use