A diffusion MRI based computer-guided assistance approach for the diagnosis of breast lesions with high accuracy and without the need for contrast agents.

This prospective study included 37 patients with 39 breast lesions. DWI images were acquired at 2 b values (200, 1500s/mm²) on a 3T-MRI scanner with a dedicated 16-channel breast coil. From the images a non-Gaussian diffusion based absolute quantitative biomarker, so-called Signature Index (S-index), was calculated by comparing tissue signals to a library of tissue reference signals to provide a classification of tumor types. The median S-index for malignant lesions was significantly higher (p < 0.0001) than for benign lesions, and the overall S-index diagnostic performance was significantly higher than BI-RADS (AUC=0.96 and 0.83, respectively), without contrast agents.