This is an interim report of an ongoing clinical trial of stereoscopic full-field digital mammography compared to standard (non-stereo) full-field digital mammography. Stereoscopic digital mammography permits the radiologist to view the internal structure of the breast directly and in depth. We compare the two modalities for detection of suspicious breast lesions in a screening population.

Over 900 patients at elevated risk for the development of breast cancer have been enrolled as of March, 2007. Each patient receives both a standard screening examination and a stereoscopic screening examination which are read independently by different radiologists. If a suspicious finding is reported from either reading, the patient is recalled for standard clinical workup examinations, which form the basis for lesion truth.

Compared to standard digital mammography, stereo mammography is reducing false positive lesion detections by 39% (p< 0.005), and reducing false negative lesion detections by 46% (p< 0.04). ROC analysis of the readers’ paired ratings of likelihood that a finding is real show greater accuracy for stereo, Az = 0.79, than for standard, Az = 0.57 (p=0.0004).

Stereo mammography is signigicantly more accurate than standard mammography in detecting lesions in breast cancer screening,improving both sensitivity and specificity.

Stereo mammography is significantly more accurate than standard mammography and has high promise of being both clinically acceptable and easily implemented for breast cancer screening.