Clinical use of high-intensity focused ultrasound (HIFU) under ultrasound or MR guidance as a non-invasive method for treating tumors is rapidly increasing. Tens of thousands of patients have been treated for uterine fibroid, benign prostate hyperplasia, bone metastases, or prostate cancer. Despite the methods' clinical potential, the liver is a particularly challenging organ for HIFU treatment due to the combined effect of respiratory-induced liver motion, partial blocking by the rib cage, and high perfusion/flow. Several technical and clinical solutions have been developed by various groups during the past 15 years to compensate for these problems. A review of current unmet clinical needs is given here, as well as a consensus from a panel of experts about technical and clinical requirements for upcoming pilot and pivotal studies in order to accelerate the development and adoption of focused ultrasound for the treatment of primary and secondary liver cancer.

Only one High Intensity Focused Ultrasound device has been clinically approved for transcranial brain surgery at the time of writing. The device operates within 650 kHz and 720 kHz and corrects the phase distortions induced by the skull of each patient using a multi-element phased array. Phase correction is estimated adaptively using a proprietary algorithm based on computed-tomography (CT) images of the patient's skull. In this paper, we assess the performance of the phase correction computed by the clinical device and compare it to (i) the correction obtained with a previously validated full-wave simulation algorithm using an open-source pseudo-spectral toolbox and (ii) a hydrophone-based correction performed invasively to measure the aberrations induced by the skull at 650 kHz. For the full-wave simulation, three different mappings between CT Hounsfield units and the longitudinal speed of sound inside the skull were tested. All methods are compared with the exact same setup thanks to transfer matrices acquired with the clinical system for N=5 skulls and T=2 different targets for each skull. We show that the clinical ray-tracing software and the full-wave simulation restore respectively 84±5% and 86±5% of the pressure obtained with hydrophone-based correction for targets located in central brain regions. On the second target (off-center), we also report that the performance of both algorithms degrades when the average incident angles of the acoustic beam at the skull surface increases. When incident angles are higher than 20°, the restored pressure drops below 75% of the pressure restored with hydrophone-based correction.

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