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

NCT03616860 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-01-23

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Focused Ultrasound (FUS) BBB Disruption

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

Sponsors & Collaborators

  • InSightec

    lead INDUSTRY

Principal Investigators

  • Nir Lipsman, MD · Sunnybrook Health Sciences Centre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-16
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03616860 on ClinicalTrials.gov