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

Trial ID or NCT#

NCT04417088

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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
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Investigator(s)

Seema Nagpal, MD
Seema Nagpal, MD
Neuro-oncologist
Clinical Professor, Neurology & Neurological Sciences Clinical Professor (By courtesy), Neurosurgery
Gordon Li, MD
Gordon Li, MD
Neurosurgeon
Professor of Neurosurgery and, by courtesy, of Neurology and of Otolaryngology - Head & Neck Surgery (OHNS)
Chirag Patel, MD, PhD

Contact us to find out if this trial is right for you.

Contact

Hari Priya Yerraballa, MBBS
650-724-9363

View on ClinicalTrials.gov