Feasible study of MRgFUS of early breast cancer - report of completion of BC006 in Japan

Among applications of MRgFUS such as uterine fibroid, breast cancer (BC), metastatice bone tumor, prostate, and the brain, the breast is prsently the only organ where complete local control of breast cancer is aimed. Immediately after completion of excision study (BC003, 2002-2003), one-arm prospective follow-up study to evaluate MRgFUS followed by adjunct radiation therapy (BC004) has been running wiht no local and systemic recurrences among 67 cases at Breastopia Namba Hospital in Japan. We report completion of excision study (BC006), the goal of which is, similar to BC003, prospective, non-randomized, single-arm, multiinternational study, and is to develop data to evaluate the safety and effectiveness of the Exablate 2000™ (InSightec, Israel) in the ablation of breast cancer by histopathological evaluation of MRI-guidance and the effect of FUS. A prospective randomized 2-arm study of MRgFUS+radiation therapy (RT) and breast conserving surgery + RT will start September, 2014.