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