Exablate Blood-Brain Barrier Disruption With Carboplatin for the Treatment of rGBM

Assessment of Safety and Feasibility of Exablate Blood-Brain Barrier Disruption (BBBD) With Microbubbles for the Treatment of Recurrent Glioblastoma (rGBM) in Subjects Undergoing Carboplatin Monotherapy

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Glioblastoma
• Intervention / Treatment: Drug: Carboplatin; Device: Exablate BBBD

Detailed Description

This is a Phase 1/2, open-label, prospective, multi-center, single-arm study to establish the safety and feasibility of blood-brain-barrier disruption (BBBD) combined with intravenous carboplatin for the treatment of rGBM using the Exablate Neuro Model 4000 Type 2 system. Adult glioblastoma subjects that are planned for carboplatin chemotherapy will be considered for study enrollment. Eligible subjects will undergo up to 6 cycles of Exablate BBBD procedures in conjunction with carboplatin chemotherapy.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
• Italy
  • Milan, Italy, 20133
    • Fondazione IRCCS Neurologico Carlo Besta
• South Korea
  • Seoul, South Korea, 120-752
    • Yonsei University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Must be between 18-80 years old
• Histologically confirmed glioblastoma
• Planned for Carboplatin monotherapy
• Be willing and able to provided written informed consent/assent
• Tumor progression after first line therapy
• 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

Exclusion Criteria:

• 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
• 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
• Difficulty lying supine and still or severe claustrophobia which cannot be managed with medication
• Severely impaired renal function
• Right to left or bi-directional cardiac shunt
• Cranial or systemic infection requiring antibiotics
• Known additional malignancy that is progression or require active treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exablate BBBD with carboplatin; 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; Carboplatin infusion on the day of Exablate BBBD procedure to treat cancerous cells in the brain; Device: Exablate BBBD; BBB opening via Exablate Neuro Type 2 system to deliver carboplatin; Other Names: Exablate Neuro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Occurrence of 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

Collaborators and Investigators

• Sponsor: InSightec

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2020
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Carboplatin; Focused Ultrasound; Exablate
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Organic Chemicals; Coordination Complexes; Carboplatin
• Other Study ID Numbers: BT009 [OUS]

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No