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

  • days left to enroll
  • participants needed
  • sponsor
Updated on 15 December 2021
glioblastoma multiforme
tumor progression


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.


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.

Condition Recurrent Glioblastoma
Treatment carboplatin, ExAblate BBBD
Clinical Study IdentifierNCT04440358
Last Modified on15 December 2021


Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note