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 Neurological Sciences 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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