Objectives This study was designed to compare the detection of subtle lesions (calcification clusters or masses) when using the combination of digital breast tomosynthesis (DBT) and synthetic mammography (SM) with digital mammography (DM) alone or combined with DBT. Methods A set of 166 cases without cancer was acquired on a DBT mammography system. Realistic subtle calcification clusters and masses in the DM images and DBT planes were digitally inserted into 104 of the acquired cases. Three study arms were created: DM alone, DM with DBT and SM with DBT. Five mammographic readers located the centre of any lesion within the images that should be recalled for further investigation and graded their suspiciousness. A JAFROC figure of merit (FoM) and lesion detection fraction (LDF) were calculated for each study arm. The visibility of the lesions in the DBT images was compared with SM and DM images. Results For calcification clusters, there were no significant differences (p > 0.075) in FoM or LDF. For masses, the FoM and LDF were significantly improved in the arms using DBT compared to DM alone (p < 0.001). On average, both calcification clusters and masses were more visible on DBT than on DM and SM images. Conclusions This study demonstrated that masses were detected better with DBT than with DM alone and there was no significant difference (p = 0.075) in LDF between DM&DBT and SM&DBT for calcifications clusters. Our results support previous studies that it may be acceptable to not acquire digital mammography alongside tomosynthesis for subtle calcification clusters and ill-defined masses. Key Points • The detection of masses was significantly better using DBT than with digital mammography alone.• The detection of calcification clusters was not significantly different between digital mammography and synthetic 2D images combined with tomosynthesis. • Our results support previous studies that it may be acceptable to not acquire digital mammography alongside tomosynthesis for subtle calcification clusters and ill-defined masses for the imaging technology used.

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The purpose of this study was to measure the threshold diameter of calcifications and masses for 2D imaging, digital breast tomosynthesis (DBT), and synthetic 2D images, for a range of breast glandularities. This study shows the limits of detection for each of the technologies and the strengths and weaknesses of each in terms of visualizing the radiological features of small cancers. Methods: Mathematical voxel breast phantoms with glandularities by volume of 9%,18%,and 30% with a thickness of 53 mm were created.Simulated ill-defined masses and calcification clusters with a range of diameters were inserted into some of these breast models. The imaging characteristics of a Siemens Inspiration X-ray system were measured for a 29 kV, tungsten/rhodium anode/filter combination. Ray tracing through the breast models was undertaken to create simulated 2D and DBT projection images. These were then modified to adjust the image sharpness, and to add scatter and noise. The mean glandular doses for the images were 1.43, 1.47, and 1.47 mGy for 2D and 1.92, 1.97, and 1.98 mGy for DBT for the three glandularities. The resultant images were processed to create 2D, DBT planes and synthetic 2D images. Patches of the images with or without a simulated lesion were extracted, and used in a four-alternative forced choice study to measure the threshold diameters for each imaging mode, lesion type, and glandularity. The study was undertaken by six physicists. Results: The threshold diameters of the lesions were 6.2, 4.9, and 6.7 mm (masses) and 225, 370, and 399 µm, (calcifications) for 2D, DBT, and synthetic 2D, respectively, for a breast glandularity of 18%. The threshold diameter of illdefined masses is significantly smaller for DBT than for both 2D (p≤0.006) and synthetic 2D (p≤0.012) for all glandularities. Glandularity has a significant effect on the threshold diameter of masses, even for DBT where there is reduced background structure in the images. The calcification threshold diameters for 2D images were significantly smaller than for DBT and synthetic 2D for all glandularities. There were few significant differences for the threshold diameter of calcifications between glandularities, indicating that the background structure has little effect on the detection of calcifications. We measured larger but nonsignificant differences in the threshold diameters for synthetic 2D imaging than for 2D imaging for masses in the 9% (p = 0.059) and 18% (p = 0.19) glandularities. The threshold diameters for synthetic 2D imaging were larger than for 2D imaging for calcifications (p < 0.001) for all glandularities.