Objective This work introduces MamoRef, an innovative whole-field, near infrared spectroscopy based device for adjunctive breast examination, aiming to help classify benign and malignant lesions in women. Utilizing low-power, non-ionizing red and near-infrared lasers, it provides metabolic information to aid physicians in characterizing lesions in BI-RADS II to IV patients, offering a non-invasive screening alternative. Approach Clinical studies were conducted, benchmarking MamoRef against conventional imaging and core biopsies. The device generates 2D maps of relative oxyhemoglobin, deoxyhemoglobin, and oxygen saturation. NIRS-specialized professionals, with basic clinical training, independently scored MamoRef images using a 6-point scale analog to BI-RADS. Scores were averaged and normalized for biopsy comparison. Main results The studied clinical cases show promising outcomes. For neoproliferative lesions, MamoRef images reveals high deoxygenated hemoglobin and diffuse high oxygenated/total hemoglobin, suggesting neovascularization around necrotic tissue. Preliminary receiver operating characteristic analysis yielded an area under the curve of 0.77. At a 0.6 threshold, MamoRef showed 70% accuracy and 74% specificity. Significance Preliminary results suggest MamoRef can potentially differentiate benign from malignant lesions detected by standard imaging. Trained clinicians might detect and characterize lesions using these metabolic maps. Further larger-scale studies are needed to validate these findings and improve the technology, positioning MamoRef as a potential low-cost, accessible adjunctive screening tool.
Carbone et al. (2026) studied this question.