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One of the main limitations to the efficacy of chemotherapy in the brain is the blood-brain barrier (BBB). Previous pre-clinical studies have demonstrated that disruption of the BBB using pulsed ultrasound in combination with an ultrasound microbubble contrast agent can significantly increase the concentration of chemotherapy agents in the brain. Our group has developed an implantable, MR compatible ultrasound device for temporarily disrupting the BBB. The safety of repeated disruption of the BBB using such a device was previously demonstrated in a long-term safety study in four non-human primates. The purpose of this work was to determine the safety and potential efficacy of temporarily disrupting the BBB in patients with recurrent glioblastoma before chemotherapy administration in a first-in-man clinical trial.

journal of therapeutic ultrasound

Temporary disruption of the blood-brain barrier using an implantable ultrasound system for recurrent glioblastoma patients under IV carboplatin chemotherapy: initial phase 1/2a clinical trial observations