Exablate Blood-Brain Barrier Disruption for the Treatment of rGBM in Subjects Undergoing Carboplatin Monotherapy

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: InSightec
• Treatments: Carboplatin

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/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