In September 2009, Real Imaging initiated IPS2, a multicenter pilot clinical study designed to both improve the technology and evaluate its performance. During the study, imaging data from healthy and newly diagnosed breast cancer patients was collected.
Six medical centers participated in this study:
Recruitment was completed in late 2011, having enrolled 434 patients including 256 healthy women undergoing routine screening mammography and 178 women with newly diagnosed breast cancer. The study was a two-phase study: an initial training and calibration phase, followed by a two-armed blinded evaluation phase (52 healthy and 66 with breast cancer). The sensitivity and specificity of 3D MIRA technology in correctly classifying the breast cancer likelihood was 90.9% and 72.5% respectively. These results suggest that 3D MIRA technology may be very useful as an adjunctive breast cancer screening tool.