Exablate Blood-Brain Barrier Disruption for the Treatment of rGBM in Subjects Undergoing Carboplatin Monotherapy
- Conditions
- Recurrent Glioblastoma
- Interventions
- Device: Exablate BBBD
- Registration Number
- NCT04417088
- Lead Sponsor
- InSightec
- 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 glioblastoma (rGBM) undergoing carboplatin monotherapy.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Exablate BBBD with carboplatin Exablate BBBD 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. Exablate BBBD with carboplatin 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.
- Primary Outcome Measures
Name Time Method Contrast intensity on MR imaging Immediately after Exablate BBBD procedure BBBD will be determined by contrast intensity in sonicated areas on T1 weighted gadolinium-based MR imaging
Adverse events Through study completion, an average of 12 months All adverse events and/or Serious Adverse Events will be documented and reported according to CTCAE criteria.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Stanford University
🇺🇸Palo Alto, California, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States