Spots Global Cancer Trial Database for Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption
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Trial Identification
Brief Title: Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption
Official Title: Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier Disruption for the Treatment of High Grade Glioma in Patients Undergoing Standard Chemotherapy
Study ID: NCT03551249
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Maryland, Baltimore, Maryland, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
University of Virginia, Charlottesville, Virginia, United States
West Virginia University, Morgantown, West Virginia, United States
Contact Details
Name: Graeme Woodworth, MD
Affiliation: University of Maryland
Role: PRINCIPAL_INVESTIGATOR
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