Clinical Trial Finder

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 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

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.

Arms

Experimental: 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.

Interventions

Drug: - Carboplatin

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

Device: - Exablate BBBD

BBB opening via Exablate Neuro Type 2 system with microbubble resonators.