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Background  Mammographic findings are seen more clearly in tomographic images with consequent improvement of Breast Imaging Reporting and Data System (BI-RADS) in categorization of indeterminate breast lesions. This study aimed to evaluate the added value of digital breast tomosynthesis (DBT) to BI-RADS classification in categorization of indeterminate breast lesions after digital mammography (DM) as an initial approach.    Methods and results  We prospectively evaluated 296 women with BI-RADS indeterminate breast lesions (BI-RADS 0, 3, and 4) by DM between January 2018 and October 2019. All patients underwent DBT. Two radiologists evaluated lesions and assigned a BI-RADS category to each lesion according to BI-RADS lexicon 2013 classification using DM, DBT, and combined DM and DBT. The results were compared in terms of main radiological features, diagnostic performance, and BI-RADS classification using histopathology as the reference standard. A total of 355 lesions were detected on DBT and 318 lesions on DM. Thirty-seven lesions were detected by DBT and not seen by DM. The final diagnoses of 355 lesions were 58.3% benign and 41.7% malignant. In comparison to DM, DBT produced 31.5% upgrading and 35.2% downgrading of BI-RADS scoring of breast lesions. DBT reduced number of BI-RADS 3 and 4, compared to DM. All upgraded BI-RADS 4 were malignant. The combination of DBT and DM significantly increased the performance of BI-RADS in the diagnosis of indeterminate breast lesions versus DM or DBT alone ( p  < 0.001).    Conclusion  Adding DBT to BI-RADS improves its diagnostic performance in detection and characterization of mammography indeterminate breast lesions.

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The added value of digital breast tomosynthesis in improving diagnostic performance of BI-RADS categorization of mammographically indeterminate breast lesions