Neoplasms

All Conditions

Rare Diseases

Glioblastoma

Glioma

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

The ExAblate Model 4000 Type 2 system is intended for use as a tool to induce localized and temporary blood-brain barrier disruption in patients with glioblastoma undergoing initial standard of care chemotherapy.

FUS involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct body targets.

Focused ultrasound (FUS)

Graeme Woodworth, MD

The purpose of this study is to evaluate the safety of the ExAblate Model 4000 Type 2 used as a tool to disrupt the BBB (blood brain barrier) in patients with high grade glioma undergoing standard of care therapy.

This is a prospective, multi-center, single-arm study to establish the safety and feasibility of BBB (blood brain barrier) disruption along the periphery of tumor resection cavity using the ExAblate Neuro Model 4000 Type 2 (220 kHz) system. For this study, patients will be eligible to enroll in the study prior to beginning the planned adjuvant TMZ chemotherapy phase of treatment. Of note, only patients who are deemed eligible for adjuvant TMZ will be eligible for enrollment.

Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption

Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier Disruption for the Treatment of High Grade Glioma in Patients Undergoing Standard Chemotherapy

The number and severity of device and BBB disruption procedure related adverse events will be evaluated and classified according to the CTCAE

The repeatability of BBB disruption will be evaluated at each of the 6 procedures and will be evaluated through assessment of post-procedure contrast-enhanced MR imaging.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption	NCT03551249	Glioma Glioblastoma	Focused ultraso...	18 Years - 80 Years	InSightec
Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption	NCT03551249	Glioma Glioblastoma	Focused ultraso...	18 Years - 80 Years	InSightec

Spots Global Cancer Trial Database for focused ultrasound (fus)