Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors

NCT05383872 | Completed DMC FDA Device

• 1 other identifier: BT015
• Study Type: interventional
• Target: 71
• Locations: 2 countries
• Sites: 17

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type 2.0/2.1 for liquid biopsy in subjects with suspected Glioblastoma brain tumors

Conditions

Glioblastoma; Glioma; Liquid Biopsy

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  All adverse events and/or Serious Adverse Events will be documented and reported according to CTCAE

  Through study completion, up to 1 year

• Correlation with Tumor Tissue

  To demonstrate there is a correlation between patterns obtained in the panel of biomarkers evaluated in the resected tumor tissue and/or biopsy and blood sample collected post-BBBD

  Up to 3 hours Post-BBBD

Secondary Outcomes (1)

• Circulating Free DNA

  Up to 3 hours Post-BBBD

Study Arms (1)

Exablate BBBD

EXPERIMENTAL

Using Exablate Model 4000 Type 2 for liquid biopsy in subjects with Glioblastoma

Device: Focused Ultrasound (Exablate Model 4000)

Interventions

Focused Ultrasound (Exablate Model 4000) DEVICE

BBB opening via Exablate Type 2 system with microbubble resonators and drawing blood before and after opening

Exablate BBBD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female subjects18-80 years of age who are able and willing to give informed consent, or whose legally authorized representative is willing to consent on their behalf
• Subjects with stereotactically-targetable suspected new or recurrent glioblastoma tumor on pre-operative brain imaging scans
• Subjects that are scheduled, or will be scheduled within 4 weeks, for surgical resection or biopsy per standard clinical tumor care
• Karnofsky Performance Score \>70
• Able to communicate sensations during the Exablate BBBD procedure

You may not qualify if:

• Subjects with inoperable tumors (e.g., tumor originating from the deep midline, thalamus, midbrain, cerebellum or brainstem)
• Multifocal tumors
• Tumor morphology or other imaging findings that precludes the ability to sonicate the tumor volume (including significant tumor volume outside the treatment envelope or tumor volume that exceeds the maximum sonication volume allowed, i.e. currently 110 ccs at the treatment volume level). Concern for adequate tumor coverage by sonication based on tumor morphology should be discussed with the Sponsor.
• 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
• 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
• Documented 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 (17)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92618, United States

Location

University of California San Francisco

San Francisco, California, 94107, United States

Location

UF Health Shands Hospital

Gainesville, Florida, 32608, United States

Location

Miami Cancer Institute at Baptist Health

Miami, Florida, 33176, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

University of Maryland, Baltimore & The University of Maryland Medical System

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

NYU Grossman School of Medicine

New York, New York, 10016, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27516, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

University of Texas, Southwestern

Dallas, Texas, 75390, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

West Virginia University Rockefeller Neuroscience Center

Morgantown, West Virginia, 26506, United States

Location

Sunnybrook Research Institute

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Glioblastoma; Glioma

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: May 20, 2022
• Study Start: August 8, 2022
• Primary Completion: February 21, 2025
• Study Completion: March 5, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (16)