QUANTITATIVE IMAGING & TREATMENT WITH FOCUSED ULTRASOUND

DESCRIPTION (Verbatim from Applicant's Abstract): A vital component of a successful clinical application of HIFU surgery is an accurate assessment of the treated tissue volume. It would be most beneficial if the HIFU-created lesion could be visualized and controlled in real-time so that treatment protocols could be modified to accommodate local and variable conditions in individual patients. The goal of this proposal is to upgrade the Sonablate device that would guide and control HIFU surgery by analyzing backscattered ultrasound signals. In our Phase I in vitro studies, several signal processing algorithms were successfully developed that measured changes in tissue parameters due to HIFU exposures. In this Phase II application, we propose (1) to utilize the signal processing algorithms developed in Phase I to separate the effects of cavitation and heat during HIFU surgery, (2) to perform a series of in vitro experiments to validate our signal and image processing algorithms, (3) to modify the Sonablate device to incorporate these lesion-imaging and control algorithms in real time, (4) to perform a series of in vivo experiments in animals with the modified Sonablate that would test the effectiveness of these algorithms, and (5) to perform a human feasibility study based on safe and efficacious results from the animal studies. PROPOSED COMMERCIAL APPLICATION: Prostate cancer is becoming an ever-more-frequent malady for man. Current annual market for treatment of prostate cancer in the United States is estimated around $5 billion. Currently, Focus Surgery Inc. manufactures the Sonablate TM system, which makes use of HIFU technology to treat benign prostatic hyperplasia (BPH). To extend the application of this system to treat prostate cancer, a reliable non-invasive feedback mechanism is necessary. The current proposal directly addresses this challenge. Successful completion of this project will open the enormous market of prostate cancer treatment for our Sonablate TM device.