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

NCT ID: NCT04440358

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-13
• Study Completion Date: 2023-12-31

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.

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.

Conditions

Recurrent Glioblastoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Exablate BBBD

Intervention Type: DEVICE

BBB opening via Exablate Neuro Type 2 system to deliver carboplatin

Carboplatin

Intervention Type: DRUG

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

Interventions

Exablate BBBD

BBB opening via Exablate Neuro Type 2 system to deliver carboplatin

Intervention Type: DEVICE

Carboplatin

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

Intervention Type: DRUG

Other Intervention Names

Exablate Neuro

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

InSightec

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Fondazione IRCCS Neurologico Carlo Besta

Milan, , Italy

Yonsei University Medical Center

Seoul, , South Korea

Countries

Canada; Italy; South Korea

Other Identifiers

BT009 [OUS]

Identifier Type: -

Identifier Source: org_study_id