Assessment of Safety and Feasibility of Exablate Blood-Brain Barrier Disruption (BBBD) With Microbubbles for the Treatment of Recurrent Glioblastoma (rGBM) in Subjects Undergoing Carboplatin Monotherapy
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- InSightec
- Enrollment
- 13
- Locations
- 3
- Primary Endpoint
- Occurrence of Adverse Events
Study Overview
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. 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- 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/assent
- •Tumor progression after first line therapy
- •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
- •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
Arms & Interventions
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.
Intervention: Exablate BBBD (Device)
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.
Intervention: Carboplatin (Drug)
Outcomes
Primary Outcomes
Occurrence of Adverse Events
Time Frame: 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
Contrast intensity on MR imaging
Time Frame: Immediately after Exablate BBBD procedure
BBBD will be determined by contrast intensity in sonicated areas on T1 weighted gadolinium-based MR imaging
Secondary Outcomes
No secondary outcomes reported