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ObjectiveDespite the high risk of missing lesions in mammography, the missed lesion rate is yet to be clinically established. Further, no breast phantoms with adjustable breast density currently exist. We developed a novel, adjustable-density breast phantom with a composition identical to that of actual breasts, and determined the quantitative relationship between breast density and the missed lesion rate in mammography.MethodsAn original breast phantom consisting of adipose- and fibroglandular-equivalent materials was developed, and a receiver operating characteristic (ROC) study was performed. Breast density, which is the fraction by weight of fibroglandular to total tissue, was adjusted to 25%, 50%, and 75% by arbitrarily mixing the two materials. Microcalcification, mass lesions, and spiculated lesions, each with unique characteristics, were inserted into the phantom. For the above-mentioned fibroglandular densities, 50 positive and 50 negative images for each lesion type were used as case samples for the ROC study. Five certified radiological technologists participated in lesion detection.ResultsThe mass-lesion detection rate, according to the area under the curve, decreased by 18.0% (p = 0.0001, 95% Confidence intervals [CI] = 0.1258 to 0.1822) and 37.8% (p = 0.0003, 95% CI = 0.2453 to 0.4031) for breast densities of 50% and 75%, respectively, compared to that for a 25% breast density. A similar tendency was observed with microcalcification; however, spiculated lesions did not follow this tendency.ConclusionsWe quantified the missed lesion rate in different densities of breast tissue using a novel breast phantom, which is imperative for advancing individualized screening mammography.