MamoRef: an optical mammography device using whole-field CW diffuse reflectance. Presentation, validation and preliminary clinical results

MamoRef is an mammography device that uses near-infrared light, designed to provide clinically relevant information for the screening of diseases of the breast. Using low power continuous wave lasers and a high sensitivity CCD (Charge-coupled device) that captures a diffusely reflected image of the tissue, MamoRef results in a versatile diagnostic tool that aims to fulfill a complementary role in the diagnosis of breast cancer providing information about the relative hemoglobin concentrations as well as oxygen saturation. We present the design and development of an initial prototype of MamoRef. To ensure its effectiveness, we conducted validation tests on both the theoretical basis of the reconstruction algorithm and the hardware design. Furthermore, we initiated a clinical feasibility study involving patients diagnosed with breast disease, thus evaluating the practical application and potential benefits of MamoRef in a real-world setting. Our study demonstrates the effectiveness of the reconstruction algorithm in recovering relative concentration differences among various chromophores, as confirmed by Monte Carlo simulations. These simulations show that the recovered data correlates well with the ground truth, with SSIMs of 0.8 or more. Additionally, the phantom experiments validate the hardware implementation. The initial clinical findings exhibit highly promising outcomes regarding MamoRef's ability to differentiate between lesions. MamoRef aims to be an advancement in the field of breast pathology screening and diagnostics, providing complementary information to standard diagnostic techniques. One of its main advantages is the ability of determining oxy/deoxyhemoglobin concentrations and oxygen saturation; this constitutes valuable complementary information to standard diagnostic techniques. Besides, MamoRef is a portable and relatively inexpensive device, intended to be not only used in specific medical imaging facilities. Finally, its use does not require external compression of the breast. The findings of this study underscore the potential of MamoRef in fulfilling this crucial role.