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

NCT04667715 | Withdrawn DMC FDA Device

• 1 other identifier: BT011
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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

Glioma

Outcome Measures

Primary Outcomes (2)

• Overall safety of the Exablate BBBD procedure itself as measured through the collection of adverse events

  Safety of the Exablate BBBD procedure will be evaluated by patient examination and post-procedure MRI exams assessing changes in the treated region. Adverse events will be reported by the Investigator and monitored in both treatment arms.

  Approximately 2 months

• Effectiveness of BBBD as determined by the proportion of subjects in whom a GTR is acheived

  The proportion of subjects in whom a gross total resection (actual versus planned) is achieved as measured on post-operative imaging compared to pre-resection imaging

  MRI 72 hours post resection

Secondary Outcomes (2)

• Confirmation of accuracy of Exablate BBBD targeting

  MRI immediately after the ExAblate procedure

• Return Rate for Second Surgery for Completion of Resection

  Approximately 2 months

Other Outcomes (1)

• Evaluation of circulating tumor biomarkers

  pre- and post-BBBD procedure

Study Arms (2)

Exablate Test Arm

ACTIVE COMPARATOR

Subjects will undergo ExAblate BBBD prior to their standard of care tumor removal

Device: Exablate BBBD

Control Test Arm

NO INTERVENTION

Subjects will undergo their standard of care tumor removal

Interventions

Exablate BBBD DEVICE

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

Exablate Test Arm

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female between 21-85 years of age who are able and willing to give informed consent
• Subjects with suspected Grade II, III or IV infiltrating glioma (IG) on pre-operative brain imaging scans who have a non-enhancing component and are planned for surgical resection.
• Karnofsky Performance Score 70-100
• Able to communicate sensations during the Exablate BBBD procedure

You may not qualify if:

• Tumor originating from the deep midline, thalamus, midbrain, cerebellum or brainstem.
• Multifocal tumors
• MRI or clinical findings of:
• Active or chronic infection(s) or inflammatory processes
• Acute or chronic hemorrhages, specifically any lobar microbleeds, and no siderosis, amyloid angiopathy, or macro-hemorrhages
• Intracranial thrombosis, vascular malformation, cerebral aneurysm or vasculitis
• More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp
• MR non-compatible metallic implants in the skull or the brain or the presence of unknown MR unsafe devices
• Significant cardiac disease or unstable hemodynamic status
• Documented myocardial infarction within six months of enrollment
• Unstable angina on medication
• Unstable or worsening congestive heart failure
• Left ventricular ejection fraction below the lower limit of normal
• History of a hemodynamically unstable cardiac arrhythmia
• Cardiac pacemaker

Sponsors & Collaborators

• InSightec: lead

Study Sites (2)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Graeme Woodworth, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent Reviewers (neurosurgeon/neuroradiologist), functioning as an Imaging Review Core Lab, will be blinded to the treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 16, 2020
• Study Start: October 23, 2024
• Primary Completion: October 23, 2024
• Study Completion: October 23, 2024
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)