Overview

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