Maryellen L. Giger PhD, Presenter: Stockholder, Hologic, Inc Shareholder, Quantitative Insights, Inc Royalties, Hologic, Inc Royalties, General Electric Company Royalties, MEDIAN Technologies Royalties, Riverain Medical Royalties, Mitsubishi Corporation Royalties, Toshiba Corporation Researcher, Koninklijke Philips Electronics NV Researcher, U-Systems, Inc

Dave P. Miller, Abstract Co-Author: Employee, ICON plc

Jeremy Bancroft Brown, Abstract Co-Author: Nothing to Disclose

Marc F. Inciardi MD, Abstract Co-Author: Investigator, U-Systems, Inc Advisor, U-Systems, Inc Consultant, Hologic, Inc

Charles Edgar Metz PhD, Abstract Co-Author: Royalties, Abbott Laboratories Royalties, General Electric Company Royalties, Hologic, Inc Royalties, Median Technologies Royalties, Mitsubishi Corporation Royalties, Riverain Medical Royalties, Toshiba Corporation Research funding, U-Systems, Inc Consultant, VuCOMP, Inc

Yulei Jiang PhD, Abstract Co-Author: Research funded, U-Systems, Inc Consultant, U-Systems, Inc

Rachel Frydman Brem MD, Abstract Co-Author: Board of Directors, iCAD, Inc Board of Directors, Dilon Technologies LLC Stock options, iCAD, Inc Stockholder, Dilon Technologies LLC Consultant, U-Systems, Inc Consultant, Dilon Technologies LLC Consultant, Dune Medical Devices Ltd

Robert M. Nishikawa PhD, Abstract Co-Author: Shareholder, Hologic, Inc Royalties, Hologic, Inc Royalties, Mitsubishi Corporation Royalties, MEDIAN Technologies Royalties, Toshiba Corporation Royalties, Riverain Medical

Alexandra V. Edwards, Abstract Co-Author: Nothing to Disclose

John Papaioannou MSc, Abstract Co-Author: Stockholder, Hologic, Inc

To conduct a multi-reader, multi-case Clinical Reader Study to evaluate the use of automated breast ultrasound (ABUS) in conjunction with mammography (XRM) in the breast cancer screening of women with dense breasts

The IRB-approved, sequential design Reader Study included a cancer-enriched set of screening XRM and ABUS exams from asymptomatic women with breast density BI-RADS 3 or 4. Readers were 17 MQSA-qualified radiologists who first interpreted XRM Alone, and then interpreted the combined XRM+ABUS. The primary analysis was performed on 164 cases: 133 non-cancers and 31 biopsy-proven cancers that had been clinically mammographically-screened as negative (BI-RADS 1 or 2). ROC analysis assessed each Reader’s interpretation of a screening mammogram exam alone (XRM) vs. the same Reader’s interpretation of the same screening mammogram paired with an ABUS exam (XRM+ABUS). Using the area under the ROC curve (AUC), Readers' performance with XRM alone was compared to their performance with XRM+ABUS.

Mean AUC across all Readers was 0.604 (95%CI: 0.535, 0.672) for XRM Alone and 0.747 (CI: 0.671, 0.822) for XRM+ABUS, yielding a statistically significant improvement in AUC of 0.143 (CI: 0.074, 0.212; p<0.001). Using a BI-RADS cut point of 3, the overall sensitivity for these cancers across all Readers was 38.8% for XRM Alone and 63.1% for XRM+ABUS, yielding an increase in sensitivity of 23.3% (CI: 10.7%, 37.9%; p<0.002). The overall specificity across all Readers was 78.0% for XRM Alone and 76.0% for XRM+ABUS, yielding a change in specificity of -2.0% (CI: -7.7%, 4.3%; p=0.518). Many of the additional cancers found with this multi-modal screening paradigm were invasive, node-negative breast cancers.

Results from the Reader study demonstrated that use of screening mammography with ABUS provides a statistically significant improvement in a Reader’s ability to detect mammography-negative breast cancers in women with >50% parenchymal breast density, as compared to mammography alone, and that this statistically significant gain in sensitivity was not accompanied by a statistically significant reduction in specificity.

Addition of ABUS to screening mammography is expected to yield a benefit to patients with dense breast tissue by providing earlier detection of breast cancers that might be missed by mammography.

Giger, M, Miller, D, Bancroft Brown, J, Inciardi, M, Metz, C, Jiang, Y, Brem, R, Nishikawa, R, Edwards, A, Papaioannou, J, Clinical Reader Study Examining the Performance of Mammography and Automatic Breast Ultrasound in Breast Cancer Screening.  Radiological Society of North America 2012 Scientific Assembly and Annual Meeting, November 25 - November 30, 2012 ,Chicago IL. http://archive.rsna.org/2012/12029472.html