Tissue change monitoring (TCM) during HIFU is an essential required feedback during the HIFU treatment. The Sonablate 500 (SB500) HIFU is enhanced with quantitative, real-time TCM software that estimate changes in tissue properties due to HIFU treatment of prostate cancer. TCM generates energy reading based on spectral analysis of the two-dimensional rf backscattered ultrasound signals acquired during HIFU. These energy changes are correlated to tissue temperature. TCM results are overlaid on the real-time ultrasound image in green, yellow, and orange to represent low, medium, and high degree of change in backscattered energy levels. To validate the TCM process five patients with histologically confirmed, organ confined prostate cancer were enrolled for the study. Needles containing three thermocouples were placed transperineally under TRUS guidance in the prostate to monitor temperatures from focal zone, posterior to the focal zone and on the lateral gland where no HIFU was applied. The measured temperatures in the HIFU treatment zones were from 70–114 °C (average 84 °C). The TCM results, estimated tissue temperatures were from 75 to 100 °C for 83% of treatment sites with an average tissue temperature of 91 °C.

01 May 2006·The Journal of the Acoustical Society of America

Noninvasive prostate surgery using high-intensity focused ultrasound

Author: Sanghvi, Narendra T.

The salient features of ultrasound are to provide both medical diagnostic and therapeutic applications due to its short wavelength in soft tissue. These combinations have motivated us to apply ultrasound for the noninvasive surgery of the prostate diseases for both benign and malignant tumors. Over a decade of engineering and clinical research a successful transrectal ultrasound device, the Sonablate, has been developed and clinically practiced for the treatment of localized prostate cancer as well as benign prostatic hyperplasia. The main advantages of using the Sonablate device are on-line imaging of the prostate in 2D and 3D, accurate therapy planning, and real-time monitoring of treatment. The long-term, over 6 years follow-up clinical results from two multicenter clinical studies indicate no severe long-lasting side effects and acceptable efficacy of the treatment. The primary benefits of this treatment are fewer complications, outpatient procedure, and very quick recovery. The presentation will include design of the device, characterization of therapy and imaging transducer, and treatment parameters for the effective clinical results.

01 Apr 2003·The Journal of the Acoustical Society of America

Detection theory applied to high intensity focused ultrasound (HIFU) treatment evaluation

Author: Crum, Lawrence ; Wunderlich, Adam ; Seip, Ralf ; Sanghvi, Narendra ; Dines, Kris ; Baily, Michael ; Tavakkoli, Jahangir

The aim of this work is to develop a HIFU treatment evaluation algorithm based on 1-D pulse/echo (P/E) ultrasound data taken during HIFU exposures. The algorithm is applicable to large treatment volumes resulting from several overlapping elementary exposures. Treatments consisted of multiple HIFU exposures with an on-time of 3 seconds each, spaced 3 mm apart, and an off-time of 6 seconds in between HIFU exposures. The HIFU was paused for approximately 70 milliseconds every 0.5 seconds, while P/E data was acquired along the beam axis, using a confocal imaging transducer. Data was collected from multiple in vitro and in vivo tissue treatments, including shams. The cumulative energy change in the P/E data was found for every HIFU exposure, as a function of depth. Subsequently, a likelihood ratio test with a fixed false alarm rate was used to derive a positive or negative lesion creation decision for that position. For false alarm rates less than 5%, positive treatment outcomes were consistently detected for better than 90% of the HIFU exposures. In addition, the algorithm outcome correlated to the applied HIFU intensity level. Lesion formation was therefore successfully detected as a function of dosage. [Work supported by NIH SBIR Grant 2 R 44 CA 83244-02.]

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