Exablate Blood-Brain Barrier Disruption for the Treatment of rGBM in Subjects Undergoing Carboplatin Monotherapy

NCT04417088 | Completed Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: BT009
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to evaluate the safety and feasibility of the Exablate Model 4000 Type 2 system when used as a tool to open the blood-brain-barrier (BBB) in subjects with recurrent glioblastoma (rGBM) undergoing carboplatin monotherapy.

Conditions

Recurrent Glioblastoma

Keywords

Exablate; Focused Ultrasound; rGBM

Outcome Measures

Primary Outcomes (2)

• Adverse events

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

  Through study completion, an average of 12 months

• Contrast intensity on MR imaging

  BBBD will be determined by contrast intensity in sonicated areas on T1 weighted gadolinium-based MR imaging

  Immediately after Exablate BBBD procedure

Study Arms (1)

Exablate BBBD with carboplatin

EXPERIMENTAL

Carboplatin will be administered via IV infusion about every 4 weeks for up to 6 cycles. The dosage will be calculated based on subject's creatinine level. On the day of planned carboplatin therapy, subjects will undergo Exablate procedure to open the blood-brain-barrier in the targeted cancerous brain areas prior to Carboplatin administration.

Drug: Carboplatin; Device: Exablate BBBD

Interventions

Carboplatin DRUG

Carboplatin infusion on the day of Exablate BBBD procedure to treat cancerous cells in the brain

Exablate BBBD with carboplatin

Exablate BBBD DEVICE

BBB opening via Exablate Neuro Type 2 system with microbubble resonators.

Also known as: Exablate Neuro

Exablate BBBD with carboplatin

Eligibility Criteria

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

You may qualify if:

• Must be between 18-80 years old
• Histologically confirmed glioblastoma
• Planned for Carboplatin monotherapy
• Be willing and able to provided written informed consent/asent
• Tumor progression after first line chemo radiation
• Recovered to grade 0 or 1 or pre-treatment baseline from clinically significant toxic effects of prior therapy
• Women of childbearing potential is confirmed not pregnant. Male and Female subjects utilize highly effective contraception
• Able to communicate verbally

You may not qualify if:

• Acute intracranial hemorrhage
• Ferrous metallic implanted objects in the skull or brain
• Prior toxicity with carboplatin chemotherapy
• Women who are pregnant or breastfeeding
• Cerebellar spinal cord or brain stem tumor
• Known active Hepatitis B or Hepatitis C or HIV
• Significant depression not adequately controlled
• Has previously received anti-VEGF or anti-VEGF agents like Avastin
• Cardiac disease or unstable hemodynamics
• Severe hypertension
• History of a bleeding disorder, coagulopathy or with a history of spontaneous tumor hemorrhage
• Active drug or alcohol use disorder
• Known sensitivity to gadolinium-based contrast agents
• Known sensitivity or contraindications to ultrasound contrast agent or perflutren
• Unable to undergo MRI or contraindications to MRI such as non-MRI compatible implanted devices

Sponsors & Collaborators

• InSightec: lead

Study Sites (4)

Stanford University

Palo Alto, California, 94304, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Carboplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 4, 2020
• Study Start: November 6, 2020
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

US (4)