Digital breast tomosynthesis: a pilot observer study.

OBJECTIVE The objective of our study was to assess ergonomic and diagnostic performance-related issues associated with the interpretation of digital breast tomosynthesis-generated examinations. MATERIALS AND METHODS Thirty selected cases were read under three different display conditions by nine experienced radiologists in a fully crossed, mode-balanced observer performance study. The reading modes included full-field digital mammography (FFDM) alone, the 11 low-dose projections acquired for the reconstruction of tomosynthesis images, and the reconstructed digital breast tomosynthesis examination. Observers rated cases under the free-response receiver operating characteristic, as well as a screening paradigm, and provided subjective assessments of the relative diagnostic value of the two digital breast tomosynthesis-based image sets as compared with FFDM. The time to review and diagnose each case was also evaluated. RESULTS Observer performance measures were not statistically significant (p > 0.05) primarily because of the small sample size in this pilot study, suggesting that showing significant improvements in diagnosis, if any, will require a larger study. Several radiologists did perceive the digital breast tomosynthesis image set and the projection series to be better than FFDM (p < 0.05) for diagnosing this specific case set. The time to review, interpret, and rate the examinations was significantly different for the techniques in question (p < 0.05). CONCLUSION Tomosynthesis-based breast imaging may have great potential, but much work is needed before its optimal role in the clinical environment is known.