Clinical trial NCT04417088: Exablate Blood-Brain Barrier Disruption for the Treatment of rGBM in Subjects 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Recurrent Glioblastoma
Keywords: Exablate
Focused Ultrasound
rGBM
Lead sponsor: InSightec
Sponsor class: INDUSTRY
First posted: 2020-06-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adverse events
timeFrame: Through study completion, an average of 12 months
measure: Contrast intensity on MR imaging
timeFrame: Immediately after Exablate BBBD procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
References: