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

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

Summary:

The purpose of this study is to evaluate the safety of blood-brain barrier (BBB) disruption in adult patients with a first presentation of a glioblastoma (GBM) following a maximal safe surgical resection and standard chemo-radiation with temozolomide (TMZ) protocol and ready for the maintenance phase of the Stupp protocol with TMZ.

Trial Description

Primary Outcome:

  • Device and procedure related adverse events
Secondary Outcome:
  • Feasibility of repeated BBB disruption will be evaluated through assessment of post-procedure contrast-enhanced magnetic resonance (MR) imaging
  • Effectiveness of BBB disruption in the treated tumour region
This is a prospective, single centre, two-arm study to establish the safety, feasibility, and effectiveness of BBB disruption along the periphery of the tumour resection cavity using the ExAblate Neuro Model 4000 Type 2.0 (220 kHz) system and DEFINITY ultrasound contrast in patients with GBM. Adult patients with a first time diagnosis of GBM, whom have undergone maximal safe surgical resection and have safely completed the initial phase of concurrent chemo-radiation therapy, will be recruited for this study. Ten patients will undergo serial treatments with FUS coincident with their standard TMZ cycles. Another 10 patients who are eligible for the maintenance phase of TMZ will be followed without intervention for disease status over time.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society