FPO TEXT A clinical trial published in the October issue of Radiology, demonstrates that the Aurora Dedicated Breast MRI System led to better diagnostic performance for all metrics (sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), and receiver operating characteristic (ROC) area) than has been historically reported in trials for breast MRI on whole-body MRI scanners. In addition, the low frequency of false positive and false negative findings associated with the dedicated breast MRI system allows for use of breast MRI with low risk of patient harm in both the screening and diagnostic environments. The study was managed by ACR Image Metrix, the American College of Radiology�s clinical research organization.

 

The results of this multi-center trial validate what we have suspected for many years, which is, using a dedicated MRI system optimized for breast imaging results in superior diagnostic performance. In addition, we were able to demonstrate consistency of performance across a variety of breast imaging centers; university, community hospital, and independent breast center said Steven Harms, MD, primary investigator for the study.

 

The study included over 900 patients and resulted in sensitivity and specificity for the dedicated breast MRI system of 92%(92/100) and 88.9% (741/834), respectively. For all cases, the negative predictive value (NPV) was 98.9% (741/749). The NPV for screening cases was 100% (326/326). The area under the receiver operating characteristic (ROC) curve was 94.2%. The false positive rate was 93/834 (11%) for all cases, but only 16/326 (4.7%) for the screening cohort Alan Hollingsworth, MD, medical director, breast surgeon at Mercy Women‘s Center at Mercy Health Center, and study investigator added, "False positive rates from previously reported trials using whole-body breast MRI have typically been between 30-50%.

 

These studies have led to criticism of breast MRI for its high false positive rates, resulting in unnecessary biopsies, surgical procedures and anxiety for the patient. The dedicated breast MRI system offers a significant improvement in performance. Even within the 93 false positives, 25 (27%) were high-risk histologies for which excision (removal) is often recommended. This kind of performance should provide breast radiologists and surgeons alike a higher level of diagnostic confidence, and could have significant impact on the role of breast MRI".

 

About Aurora Imaging Technology, Inc.

Aurora Imaging Technology Inc. is a private company based in North Andover, Mass. committed to the fight against breast cancer. Aurora strives to manufacture the highest quality and most cost-effective breast MRI solutions, and partners with a growing number of the world's finest breast care centers to provide the ultimate in the detection, diagnosis, biopsy and management of breast cancer. The Aurora Breast MRI System is in clinical use at a rapidly growing number of leading breast care centers in the U.S., Europe and Asia. For more information please visit www.auroramri.com.