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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Exablate BBBD with carboplatin
Carboplatin will be administered via IV infusion about every 4 weeks for up to 6 cycles. The dosage will be calculated based on subject's creatinine level. On the day of planned carboplatin therapy, subjects will undergo Exablate procedure to open the blood-brain-barrier in the targeted cancerous brain areas prior to Carboplatin administration.
  • Drug: Carboplatin
    Carboplatin infusion on the day of Exablate BBBD procedure to treat cancerous cells in the brain
  • Device: Exablate BBBD
    BBB opening via Exablate Neuro Type 2 system with microbubble resonators.
    Other names:
    • Exablate Neuro

Recruiting Locations

University of Maryland
Baltimore, Maryland 21201
Contact:
Kaitlyn Henry
410-328-0939
KHenry@som.umaryland.edu

More Details

Status
Recruiting
Sponsor
InSightec

Study Contact

Julia Zhu
469-607-0491
juliaz@insightec.com

Detailed Description

This is a Phase 1/2, open-label, prospective, multi-center, single-arm study to establish the safety and feasibility of blood-brain-barrier disruption (BBBD) combined with intravenous carboplatin for the treatment of rGBM using the Exablate Neuro Model 4000 Type 2 system with microbubble resonators. Adult glioblastoma subjects that are planned for carboplatin chemotherapy will be considered for study enrollment. Eligible subjects will undergo up to 6 cycles of Exablate BBBD procedures in conjunction with carboplatin chemotherapy.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.