Assessment of Safety and Feasibility of Exablate Type 2 for Blood- Brain Barrier Disruption (BBBD) with Micro bubble Resonators for the Treatment of Recurrent Glioblastoma (rGBM) in Subjects Undergoing Carboplatin Monotherapy

Protocol # :
Recurrent Glioblastoma
Disease Sites
Brain and Nervous System
Principal Investigator
Golby, Alexandra
Site Research Nurses
Chau, Johny, E.
Donohoe, Aisling
Litchfield, Ashley

Trial Description

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.

Eligibility Requirements

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/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

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

- 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

- 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

- 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