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Safety and Effectiveness of Blood-Brain Barrier Disruption (BBBD) in Subjects With Suspected Infiltrating Glioma

NCT04667715 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-05-02

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and effectiveness of using the Exablate Type 2 system using microbubble resonators (Exablate Test Arm) to disrupt the Blood-Brain Barrier for the purpose of temporarily transforming, and thereby 'marking', regions of infiltrating gliomas prior to planned surgical resection, for the purpose of improving tumor visualization during the surgery to achieve a greater proportion of subjects who receive a Gross Total Resection (GTR) per plan compared to those not undergoing a BBBD procedure prior to resection (Control Arm).

Conditions

Interventions

DEVICE

Exablate BBBD

Blood brain barrier disruption using ExAblate Type 2 device using microbubble resonators

Sponsors & Collaborators

  • InSightec

    lead INDUSTRY

Principal Investigators

  • Graeme Woodworth, MD · University of Maryland, Baltimore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-23
Primary Completion
2024-10-23
Completion
2024-10-23
FDA Device
Yes

Countries

  • United States

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 NCT04667715 on ClinicalTrials.gov