SBIR-STTR Award

The goal of our work is to develop a new generation of commercial ultrasound applicators and associated hardware/software capable of improved heating uniformity and controllability at various depths within the body, with specific application, for the first time, to thermal therapy for breast cancer and chest wall recurrence. Such thermal therapy, used in conjunction with conventional radiation therapy, has been shown to be safe and effective in a number of clinical studies. These new applicator designs are based on extensive clinical experience with the SONOTHERM(R) 1000 multichannel ultrasound hyperthermia system, an FDA approved system now in clinical use in over 35 clinical sites around the world. The applicators will be developed speclfically for use with that system, though some hardware Phase I Grants and software modifications will be necessary to accept the new applicators. Phase I goals are to improve the performance of the SONOTHERM (R) system for treatment of breast and chest wall lesions 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 the ultrasound applicator array, and (c) improved means for coupling these new applicators for breast and chest wall treatments. Phase II will be devoted to the construction of clinical testing versions of applicators and other ancillary hardware and software developed during Phase 1, and to conduct FDA sanctioned clinical trials at selected sites within the SONOTHERM(R) 1000 user base in the U.S. to determine the safety and effectiveness of the new devices.Commercial ApplicationsThis research offers the potential of improving the performance of an already mature product, the SONOTHERM (*trade mark symbol) 1000 ultrasound hyperthermia system. This product received FDA approval in 1989, and is installed at more than 35 sites around the world. The ability to build on this already proven technology offers a unique opportunity to efficiently bring new ideas and improved technology to bear on the treatment of breast cancer. There are no other devices of this kind commercially available, though their need in the clinical environment is well known.National Cancer Institute (NCI)

The proposed work seeks to continue development of a new generation of commercial ultrasound applicators and associated hardware/software capable of improved heating uniformity and controllability at various depths within the body, with specific application to thermal therapy for breast cancer and chest wall recurrence. These new applicator designs are based on extensive clinical experience with the SONOTHERM 1000 multichannel ultrasound hyperthermia system now in clinical use at over 36 sites around the world, as well as earlier Phase I studies. The goal of Phase II is to construct and test applicators and control software specifically for use with the SONOTHERM-TM system which offer (a) higher frequency operation to limit penetration depth where indicated; (b) simultaneous dual frequency operation to provide depth of penetration control over the face of the ultrasound applicator array; and (c) improved means for coupling these new applicators for breast and chest wall treatments. Since development of electronic hardware modifications to implement simultaneous dual frequency operation was completed in Phase I, the present effort will be focused on the implementation of the new applicators and control software, and to their pre-clinical testing.Proposed Commercial Applications:There is presently a resurgence of interest in hyperthermia which is spreading world wide owing to recent reports in Europe of favorable results of randomized trials. With about 2800 cancer therapy sites worldwide, a small number of active clinical hyperthermia sites, the full potential of this therapy has yet to be realized. FDA Pre-Market Approval, and recognized advanced technology, favorably positions Labthermics to benefit from the increased awareness of the effectiveness of modern hypothermia therapy.