According to the available scientific evidence, there is insufficient information on the efficacy / effectiveness, safety and cost-effectiveness of HIFU treatment in patients with solid tumours (primary or metastatic). In fact, the design and the few studies published limit the proper assessment of the impact of HIFU treatment. Hence, it is necessary to conduct randomised, properly designed trials with a sufficiently large sample size to further assess the use of HIFU in the surgical treatment of solid tumours.