Read independent clinical evaluation by Thomas Jefferson University Hospital

Currently, breast biopsy serves as the key diagnostic tool in the evaluation of breast masses for malignancy. Unfortunately, breast biopsy is neither a benign nor an inexpensive process. Besides affecting patients physically and emotionally, the procedure frequently causes internal scarring, which obscures the results of future mammograms. Until fairly recently, ultrasound in the U.S. has been used only to distinguish cystic from solid breast masses and to guide needle biopsies. A number of positive studies in Europe, Asia and the U.S. indicate that high-quality ultrasound can provide radiologists with a high degree of confidence in differentiating many benign from malignant or suspicious lesions detected by mammography.

Almen Laboratories has developed a sophisticated software system for imaging applications that provides extensive tools to identify objects and image features of interest, analyze the information content and then store, retrieve and compare different objects and images of interest based on this information.  During last 7 years and in collaboration with UCSD School of Medicine and VAH San Diego this software system was tailored to the needs of diagnostic breast ultrasound. The implemented CAD was validated on IRB (Institutional Review Board) approved cohorts of cases with available confirmation of the “truth” via needle biopsy or 12 months follow-up for non-suspicious benign lesions. This application targeted breast ultrasound, which can provide radiologists with a high degree of confidence in assessing low level of suspicion lesions (BI-RADS Category 2 and 3).

The completed product will help improve accuracy of practitioners, potentially  increasing their confidence in breast ultrasound, reduce variability of interpretations, and increase ultrasound’s role in breast cancer detection and management. The software automatically produces the radiologist created BI-RADS Report. This site is developed for the purpose of educating professionals and individuals in the developed Breast Ultrasound CAD technology and make such technology widely available for computer-aided BI-RADS Assessment and Lexicon implementation based on established and FDA approved reporting system (BI-RADS).

 

Results suggest that more accurate application of BI-RADS assessment for diagnostic ultrasound could in future help reduce the number of biopsies by 40% with a cost savings of well over $1 billion per year in the USA, mainly by reducing the number of False Positives.