A non-invasive multimodal sono-contrast NIR spectroscopy system for breast cancer diagnosis: Clinical trial

A multimodal spectroscopy system was developed to improve breast cancer diagnosis non-invasively. It includes three modules: diffuse reflectance spectroscopy (DRS), ultrasonography and low intensity focused ultrasound (LIFU). An IRB-approved clinical trial is in progress. Currently 33 patients were enrolled with informed consent. DRS signals were analyzed using wavelet technique before needle biopsy was performed for tissue diagnosis. Clinical results showed that LIFU stimulated transitory high-frequency fluctuation in non-cancer tissue, but not in malignant tissue. The average ratio of the variances during LIFU vs. baseline is 2.95 in non-cancer tissue, compared to 1.18 in cancer. This difference is significant (p=0.0007), indicating that high-frequency fluctuation was amplified in non-cancer tissue during LIFU. Current clinical results demonstrate the effectiveness of this promising technique in characterizing cancer vs. non-cancer tissues. Combining this system with breast ultrasound has the potential to increase the specificity of sonographic breast cancer detection, and to reduce unnecessary invasive procedures.