The first human trial of a novel ultrasound device demonstrated its potential to temporarily open the blood-brain barrier and deliver chemotherapy directly to the brain. This innovative procedure led to a significant increase of four to six times in drug concentrations in the brain, and patients were awake during the four-minute procedure which was repeated every few weeks for several months.
The four-minute procedure to open the blood-brain barrier is performed with the patient awake, and patients go home after a few hours. The results show the treatment is safe and well tolerated, with some patients getting up to six cycles of treatment. This video demonstrates the dynamic opening of the BBB opening intra-operatively. Following brain sonication and administration of intravenous microbubbles, scientists injected fluorescein intravenously, as this dye does not normally penetrate into the brain. They first observed fluorescein in the arteries, then the whole brain was fluorescent, as this dye was in the capillaries, followed by the brain veins.
“There is a critical time window after sonification when the brain is permeable to drugs circulating in the bloodstream,” Sonabend said. In the phase 1 clinical trial reported in this paper, patients underwent surgery for resection of their tumors and implantation of the ultrasound device. They started treatment within a few weeks after the implantation.
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