Neuronavigation-guided focused ultrasound (NaviFUS) for transcranial blood-brain barrier opening in recurrent glioblastoma patients: clinical trial protocol.

ABSTRACT:

Background

Blood-brain barrier (BBB) limits over 95% of drugs' penetration into brain, which has been a major obstacle in treating patients with glioblastoma. Transient BBB opening in glioblastoma (GBM) is feasible by combining focused ultrasound (FUS) with systemic infusion of microbubbles (MB). NaviFUS, a novel device that integrates neuronavigation and FUS-MB system, is able to intraoperatively direct the ultrasound energy precisely and repeatedly at targeted CNS areas. This clinical trial evaluates the safety and feasibility of NaviFUS in recurrent glioblastoma patients.

Methods

The study is a first-in-human, prospective, open-label, single-center, single-arm, dose escalation phase 1 clinical trial. A total of 6 patients will be enrolled. Patients will be enrolled into t

SUBMITTER: Chen KT 

PROVIDER: S-EPMC7327352 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature