Status:
ACTIVE_NOT_RECRUITING
Exablate Blood-Brain Barrier Disruption for the Treatment of rGBM in Subjects Undergoing Carboplatin Monotherapy
Lead Sponsor:
InSightec
Conditions:
Recurrent Glioblastoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
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 gliobl...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04417088
Start Date
November 6 2020
End Date
July 1 2024
Last Update
March 5 2024
Active Locations (4)
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1
Stanford University
Palo Alto, California, United States, 94304
2
University of Maryland
Baltimore, Maryland, United States, 21201
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195