Validation of tissue change monitoring (TCM) on the Sonablate® 500 during high intensity focused ultrasound (HIFU) treatment of prostate cancer with real-time thermometry

The Sonablate® 500 has quantitative, real-time Tissue Change Monitoring (TCM) software that estimates changes in tissue properties due to HIFU treatment of prostate cancer. This study validates the Sonablate 500 TCM system using real-time thermometry. Five patients with histologically confirmed, organ-confined prostate cancer were enrolled. Four patients with focal cancer had hemiablation and one had whole gland ablation. TCM generates energy reading based on spectral analysis on the RF backscattered ultrasound signals; results are used as an estimator of tissue temperature. Needle 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 HIFU treatments averaged 37, 35 and 19.7 Watts for the treatment for anterior, middle and posterior zones. The measured temperatures (Average, Max, and Min) in the HIFU treatment zones were 84, 114 and 70 degrees C. The temperature estimated by TCM energy readings were 83% 75-100 degrees C and 17% 60-75 degrees C with an average of 91 degrees C. Outside the focal zone, average recorded temperature was 50 degrees C. Average temperature in the lateral lobe where no HIFU was applied was 40.7 degrees C.