Safety of focused ultrasound in neuro-oncology: A summary of preclinical and clinical work.

Overview

Focused ultrasound (FUS) has emerged as a promising technology in neuro-oncology with applications across both treatment and diagnosis of brain tumors. This review consolidates both preclinical and clinical evidence on the safety of the 2 primary FUS modalities, low-intensity focused ultrasound and high-intensity focused ultrasound. Safety data discussed has a particular emphasis on blood-brain barrier disruption, tissue effects, and neuroinflammatory responses. Although the field is advancing rapidly, comprehensive safety data remains fragmented across studies. With the current lack of standardization across FUS devices, treatment parameters, and microbubble characteristics, it is critical to summarize all currently available safety data to provide direction for the field. This review also aims to provide context for the vast amount of preclinical work into translatable data that can be used to justify and guide future clinical trials. Finally, the application of FUS in the pediatric population is discussed, along with special considerations and a current view on ongoing clinical trials.