Education and Training
Exablate Blood-Brain Barrier Disruption for the Treatment of rGBM in Subjects Undergoing Carboplatin Monotherapy
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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Carboplatin
- device: Exablate BBBD
Eligibility
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
Ages Eligible for Study
18 Years - 80 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Hari Priya Yerraballa, MBBS
650-724-9363
Not Recruiting