Second Generation Commercial Ultrasound Therapy Arrays

The goal of our work is to develop a new generation of commercial ultrasound applicators andassociated hardware/software capable of improved heating uniformity and controllability at variousdepths within the body, with specific application, for the first time, to thermal therapy for breast cancerand chest wall recurrence. Such thermal therapy, used in conjunction with conventional radiationtherapy, has been shown to be safe and effective in a number of clinical studies. These new applicatordesigns are based on extensive clinical experience with the SONOTHERM(R) 1000 multichannelultrasound hyperthermia system, an FDA approved system now in clinical use in over 35 clinical sitesaround the world. The applicators will be developed specifically for use with that system, though somehardware and software modifications will be necessary to accept the new applicators. Phase I goals areto improve the performance of the SONOTHERM (R) system for treatment of breast and chest walllesions by examining (a) higher frequency applicator operation to limit penetration depth where indicated,(b) simultaneous multifrequency operation to provide depth of penetration varying over the face of theultrasound applicator array, and (c) improved means for coupling these new applicators for breast andchest wall treatments. Phase II will be devoted to the construction of clinical testing versions ofapplicators and other ancillary hardware and software developed during Phase I, and to conduct FDAsanctioned clinical trials at selected sites within the SONOTHERM(R) 1000 user base in the U.S. todetermine the safety and effectiveness of the new devices.