Study

Condition & Participants

Device & Treatment Specifications

Key Findings

Mainprize, et al. [83]

Glioblastoma Multiforme (GBM), 5 patients

Utilized ExAblate helmet array with microbubble (MB) injections; a single session conducted before tumor excision. Specifications: 220 kHz frequency, 50% of cavitation threshold. Targeted Area: Tumor margins, measuring 9 × 9 × 6 mm³

Gadolinium-enhanced MRI verified BBB disruption in peritumoral regions immediately post-sonication. Elevated chemotherapy levels detected in the sonicated areas of 2 patients.

Idbaih, et al. [86]

Recurrent GBM, 19 patients

SonoCloud1 implantable device paired with MB injections followed by intravenous carboplatin. On average, 3 treatment sessions, spaced 4 weeks apart. Specifications: 1 MHz frequency, pressure range 0.41-1.15 MPa (dose escalation)

BBB disruption was successful in 52 out of 65 sonication attempts, with increased effectiveness at higher acoustic pressures. Post-treatment edema occurred in 2 patients, which was responsive to steroid treatment. The study suggested that patients with moderate BBB disruption (grade 2/3) tended to have longer progression-free survival (PFS) and overall survival (OS).

Anastasiadis, et al. [87]

Infiltrative Glioma (WHO grades 2 and 3), 4 patients

ExAblate helmet array with combined with the injection of MB, followed by fluorescein, and ending with surgical excision. Specifications: 230 kHz frequency, power set at 50% of cavitation threshold (mean range: 3-26 W). Targeted Volume: 0.5 cm³ for patients 1-3, 10 cm³ for patient 4

No serious adverse events (SAEs) occurred. MRI with gadolinium and intraoperative fluorescence confirmed increased BBB permeability in targeted regions, as validated by histopathological analysis.

Meng, et al. [84]

HER2-positive breast cancer metastasis to the brain, 4 patients

ExAblate helmet array with MB infusion. Specifications: 220 kHz frequency, mean power of 13 W. Entire tumor volumes targeted, with a mean volume of 27 cm³

Full tumor volumes, including lesions in the posterior fossa, were successfully targeted. No SAEs reported. Trastuzumab delivery to the brain was confirmed via SPECT imaging, and all patients showed a reduction in tumor size.

Sonabend, et al. [88]

Newly resected recurrent GBM, 17 patients

SonoCloud9 implantable device with MB injection. Up to 6 treatments (median 3), followed by intravenous paclitaxel administration with dose escalation. Target: Borders of the resection cavity, mean volume of 12.6 mL

No SAEs reported. BBB was effectively disrupted, with recovery beginning as soon as 1-hour post-treatment. Some patients experienced temporary neurological effects (e.g., paresthesias, aphasia) related to brain regions near the sonication zones. Reversible encephalopathy occurred in two patients at elevated paclitaxel doses.