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

Not Recruiting

Trial ID: NCT04417088

Purpose

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.

Official Title

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

Stanford Investigator(s)

Seema Nagpal, MD
Seema Nagpal, MD

Clinical Professor, Neurology & Neurological Sciences Clinical Professor (By courtesy), Neurosurgery

Gordon Li, MD
Gordon Li, MD

Professor of Neurosurgery and, by courtesy, of Neurology and of Otolaryngology - Head & Neck Surgery (OHNS)

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

Intervention(s):

drug: Carboplatin

device: Exablate BBBD

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Hari Priya Yerraballa, MBBS
650-724-9363

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