Safety and Feasibility Study of ExAblate 4000 Treatment for Benign Centrally-Located Brain Tumors in Children and Young Adults

What this Trial Is About

Researchers are evaluating the safety and feasibility of using the ExAblate 4000 system to treat benign centrally-located intracranial tumors in children and young adults who need clinical intervention. This prospective, non-randomized, single-arm feasibility study focuses on tumors that are accessible to the ExAblate 4000 device and aims to gather data for future research. The study does not include formal hypothesis testing but seeks to understand treatment safety and tumor management. Participants will receive focused ultrasound treatment using the ExAblate 4000 system targeting benign brain tumors. This study involves a single treatment arm where all participants receive the investigational device therapy. The treatment is designed for subjects with tumors meeting specific criteria, including minimal hemorrhage risk and accessibility to the device. During the study, participants will be closely monitored from the procedure day through a 12-month follow-up period. Researchers will assess safety by tracking treatment-emergent adverse events and measure tumor volume changes over time. Additional evaluations include neurological exams, physical exams, visual field testing, and both clinician and patient impressions of change. Participants andor their caregivers will maintain seizure diaries, and the study includes regular follow-ups to evaluate overall health and neurological status.

A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult Subjects