Planar 2D x-ray mammography is generally accepted as the preferred screening technique used for breast cancer detection. Recently, digital breast tomosynthesis (DBT) has been introduced to overcome some of the inherent limitations of conventional planar imaging, and future technological enhancements are expected to result in the introduction of further innovative modalities. However, it is crucial to understand the impact of any new imaging technology or methodology on cancer detection rates and patient recall. Any such assessment conventionally requires large scale clinical trials demanding significant investment in time and resources. The concept of virtual clinical trials and virtual performance assessment may offer a viable alternative to this approach. However, virtual approaches require a collection of specialized modelling tools which can be used to emulate the image acquisition process and simulate images of a quality indistinguishable from their real clinical counterparts. In this paper, we present two image simulation chains constructed using modelling tools that can be used for the evaluation of 2D-mammography and DBT systems. We validate both approaches by comparing simulated images with real images acquired using the system being simulated. A comparison of the contrast-to-noise ratios and image blurring for real and simulated images of test objects shows good agreement ( < 9% error). This suggests that our simulation approach is a promising alternative to conventional physical performance assessment followed by large scale clinical trials.

Abstract. A new method of generating realistic three dimensional simulated breastrealistic masses with more variability in shape compared to the RW method. DLA 24 generated lesions can overcome the lack of complexity in structure and shape in many 25 current methods of mass simulation.

Digital breast tomosynthesis (DBT) is under consideration to replace or to be used in combination with 2D-mammography in breast screening. The aim of this study was the comparison of the detection of microcalcification clusters by human observers in simulated breast images using 2D-mammography, narrow angle (15°/15 projections) and wide angle (50°/25 projections) DBT. The effects of the cluster height in the breast and the dose to the breast on calcification detection were also tested. Simulated images of 6 cm thick compressed breasts were produced with and without microcalcification clusters inserted, using a set of image modelling tools for 2D-mammography and DBT. Image processing and reconstruction were performed using commercial software. A series of 4-alternative forced choice (4AFC) experiments was conducted for signal detection with the microcalcification clusters as targets. Threshold detectable calcification diameter was found for each imaging modality with standard dose: 2D-mammography: 2D-mammography (165  ±  9 µm), narrow angle DBT (211  ±  11 µm) and wide angle DBT (257  ±  14 µm). Statistically significant differences were found when using different doses, but different geometries had a greater effect. No differences were found between the threshold detectable calcification diameters at different heights in the breast. Calcification clusters may have a lower detectability using DBT than 2D imaging.

Abstract. 13 Digital breast tomosynthesis (DBT) is a promising technique to overcome the tissue

A novel method has been developed for generating quasi-realistic voxel phantoms which simulate the compressed breast in mammography and digital breast tomosynthesis (DBT). The models are suitable for use in virtual clinical trials requiring realistic anatomy which use the multiple alternative forced choice (AFC) paradigm and patches from the complete breast image. The breast models are produced by extracting features of breast tissue components from digital breast tomosynthesis (DBT) clinical images including skin, adipose and fibro-glandular tissue, blood vessels and Cooper's ligaments. A range of different breast models can then be generated by combining these components. Visual realism was validated using a receiver operating characteristic (ROC) study of patches from simulated images calculated using the breast models and from real patient images. Quantitative analysis was undertaken using fractal dimension and power spectrum analysis. The average areas under the ROC curves for 2D and DBT images were .51±.06 and .54±.09 demonstrating that simulated and real images were statistically indistinguishable by expert breast readers (7 observers); errors represented as one standard error of the mean. The average fractal dimensions (2D, DBT) for real and simulated images were (2.72±.01, 2.75±.01) and (2.77±.03, 2.82±.04) respectively; errors represented as one standard error of the mean. Excellent agreement was found between power spectrum curves of real and simulated images, with average β values (2D, DBT) of (3.10±.17, 3.21±.11) and (3.01±.32, 3.19±.07) respectively; errors represented as one standard error of the mean. These results demonstrate that radiological images of these breast models realistically represent the complexity of real breast structures and can be used to simulate patches from mammograms and DBT images that are indistinguishable from patches from the corresponding real breast images. The method can generate about 500 radiological patches (~30mm x 30mm) per day for AFC experiments on a single workstation. This is the first study to quantitatively validate the realism of simulated radiological breast images using direct blinded comparison with real data via the ROC paradigm with expert breast readers. Page 1 of 16AUTHOR SUBMITTED MANUSCRIPT -PMB-104914. R2 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 KeywordsVirtual clinical trials, breast model, breast phantom, synthetic breast, image simulation, 2D-mammography, digital breast tomosynthesis.