Completed

Blood-Brain Barrier Disruption with Exablate for Recurrent Glioblastoma Treatment

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What is being tested

Exablate BBBD

+ Carboplatin

DeviceDrug
Who is being recruted

Astrocytoma+7

+ Glioblastoma

+ Glioma

From 18 to 80 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: October 2020
See protocol details

Summary

Principal SponsorInSightec
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 13, 2020

Actual date on which the first participant was enrolled.

This study focuses on treating recurrent Glioblastoma (rGBM), a type of brain tumor, using a combination of blood-brain-barrier disruption (BBBD) and carboplatin chemotherapy. The blood-brain barrier is a protective shield that sometimes prevents medicines from reaching the brain. This study uses a device called Exablate Neuro Model 4000 Type 2 to temporarily open this barrier, allowing the chemotherapy drug, carboplatin, to reach the tumor more effectively. Adults with glioblastoma who are planned for carboplatin chemotherapy may be considered for this study. The goal is to establish the safety and feasibility of this combined approach, which could potentially improve treatment outcomes for this condition. During the study, participants will undergo up to 6 cycles of Exablate BBBD procedures in conjunction with carboplatin chemotherapy. The effectiveness of the BBBD procedure will be measured by the intensity of contrast in the treated areas on MRI scans. Any adverse events or side effects will be documented and reported according to standard medical criteria. This helps ensure the safety of the participants and provides valuable information about the potential risks and benefits of this treatment approach.

Official TitleAssessment 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
NCT04440358
Principal SponsorInSightec
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

13 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AstrocytomaGlioblastomaGliomaNeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroectodermal TumorsNeoplasms, Neuroepithelial

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Sunnybrook Health Sciences Centre

Toronto, CanadaOpen Sunnybrook Health Sciences Centre in Google Maps
Suspended

Fondazione IRCCS Neurologico Carlo Besta

Milan, Italy
Suspended

Yonsei University Medical Center

Seoul, South Korea
Completed3 Study Centers