Elizabeth Ann Rafferty MD, Presenter: Nothing to Disclose

Loren Thomas Niklason PhD, Abstract Co-Author: Employee, Hologic, Inc Patent holder, Hologic, Inc

Compare the clinical performance of FFDM (2D) to FFDM plus Tomosynthesis (2D plus 3D) for women with dense breast tissue.

An enriched case set of 293 cases including 69 cancers, 74 benign biopsies, 50 recalled screening, and 100 negative screening cases with a BIRADS density score of 3 or 4 was assembled. 73 calcification and 220 non-calcification cases were included. Radiologists were trained in the interpretation of 3D images. 8 radiologists read the cases in two separate sessions separated by one month with ½ of cases read in each mode (2D alone or 2D plus 3D) for each reading session. The scoring included identification of the lesion location and type, initial BIRADS (0, 1, or 2) to determine recall rate and a probability of malignancy score (0 to 100%). Area under the ROC curve (AUC) was used for comparison.

For all cancer cases combined, recall rates for 2D plus 3D were 9.7% higher than for 2D alone (3.8% higher for calcification cases and 14.3% higher for non-calcification cases). For non-cancer screening cases(recalls and negatives) the recall rate for 2D plus 3D was 23.3% versus 33.9% for 2D alone, a reduction in the non-cancer recall rate of 31%. The AUC for 2D vs. 2D plus 3D was 0.857 and 0.940 respectively (difference 0.083, p-value <0.0001). The AUC for calcification cases was 0.777 vs. 0.818 for 2D vs. 2D plus 3D respectively ( p-value = 0.048). The AUC for non-calcification cases was 0.867 vs. 0.977 for 2D vs. 2D plus 3D respectively (p-value = 0.0001).

Using 2D plus 3D compared with 2D alone, radiologists improved their ROC performance and increased their cancer detection rate while decreasing their non-cancer recall rate in women with radiographically dense breasts.

The combination of FFDM and Tomosynthesis (2D plus 3D) offers the potential for improved cancer detection and reduced recall rates in women with dense breasts.

Rafferty, E, Niklason, L, FFDM vs FFDM with Tomosynthesis for Women with Radiographically Dense Breasts: An Enriched Retrospective Reader Study.  Radiological Society of North America 2011 Scientific Assembly and Annual Meeting, November 26 - December 2, 2011 ,Chicago IL. http://archive.rsna.org/2011/11016626.html