Recurrent GlioblastomaPhase 1/2NCT04417088
Exablate Blood-Brain Barrier Disruption for the Treatment of rGBM in Subjects Undergoing Carboplatin Monotherapy
A Phase 1/2 study testing Carboplatin and Exablate BBBD in people with Recurrent Glioblastoma, run by InSightec at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Recurrent Glioblastoma
- What is being tested?
- Carboplatin and Exablate BBBD
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 4 sitesUnited States
- Study dates
- 6 Nov 2020to 31 Dec 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Maryland
Baltimore, Maryland, 21201
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Cleveland Clinic
Cleveland, Ohio, 44195
Stanford University
Palo Alto, California, 94304
About this study
Official title: Assessment of Safety and Feasibility of Exablate Type 2 for Blood-Brain Barrier Disruption (BBBD) With Microbubble Resonators 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.
Read the 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 with microbubble resonators. 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
- Being tested
- Carboplatin, Exablate BBBD
- Keywords
- Exablate, Focused Ultrasound, rGBM
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
Carboplatin infusion on the day of Exablate BBBD procedure to treat cancerous cells in the brain
Exablate BBBDDevice
Also called Exablate Neuro
BBB opening via Exablate Neuro Type 2 system with microbubble resonators.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Carboplatin; Device: Exablate BBBD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
All adverse events and/or Serious Adverse Events will be documented and reported according to CTCAE criteria.
Measured: 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
Measured: Immediately after Exablate BBBD procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start6 Nov 2020
- Primary completion30 Nov 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent GlioblastomaStudies of the same condition, open and under way.
- More trials run by InSightecThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417088
- Sponsor's protocol ID
- BT009
- Status last verified
- Mar 2026
- First submitted
- 1 Jun 2020
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety and Feasibility of Exablate Type 2 for Blood-Brain Barrier Disruption (BBBD) With Microbubble Resonators for the Treatment of Recurrent Glioblastoma (rGBM) in Subjects Undergoing Carboplatin Monotherapy
- ClinicalTrials.gov ID
- NCT04417088
- Acronym / sponsor ID
- BT009
- Conditions
- Recurrent Glioblastoma
- Keywords
- Exablate, Focused Ultrasound, rGBM
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 with microbubble resonators. 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exablate BBBD with carboplatin | Experimental | Drug: Carboplatin, Device: Exablate BBBDCarboplatin 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarboplatinCarboplatin infusion on the day of Exablate BBBD procedure to treat cancerous cells in the brain | Drug | Exablate BBBD with carboplatin |
| Exablate BBBDAlso: Exablate NeuroBBB opening via Exablate Neuro Type 2 system with microbubble resonators. | Device | Exablate BBBD with carboplatin |
Primary outcome
Adverse events
Time frame: Through study completion, an average of 12 months
All adverse events and/or Serious Adverse Events will be documented and reported according to CTCAE criteria.
Contrast intensity on MR imaging
Time frame: Immediately after Exablate BBBD procedure
BBBD will be determined by contrast intensity in sonicated areas on T1 weighted gadolinium-based MR imaging
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Carboplatin and Exablate BBBD in people with Recurrent Glioblastoma, run by InSightec at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Through study completion, an average of 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.