Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier Disruption for the Treatment of Glioblastoma in Patients Undergoing Standard Chemotherapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Glioblastoma Multiforme
- Sponsor
- InSightec
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Adverse Events Safety Profile
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety of the ExAblate Model 4000 Type 2.0 used as a tool to disrupt the BBB in patients with Glioblastoma undergoing standard of care therapy.
Detailed Description
This is a prospective, multisingle-center, single-arm study to establish the safety and feasibility of BBB disruption along the periphery of tumor resection cavity using the ExAblate Neuro Model 4000 Type 2.0 (220 kHz) system. For this study, patients will be eligible to enroll in the study prior to beginning the planned adjuvant TMZ chemotherapy phase of treatment. Of note, only patients who are deemed eligible for adjuvant TMZ will be eligible for enrollment. This study will enroll up to 20 subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient is eligible for adjuvant TMZ treatment based on the current standard of care.
- •Men or women.
- •Age between 19 and 80 years, inclusive.
- •Able and willing to give informed consent.
- •Grade IV glioma (GBM) confirmed through assessment of surgical specimens by a board-certified neuropathologist.
- •Combined radiation/TMZ treatment is completed based on the prescribed standard of care regimen.
- •Karnofsky rating 70-100 (See Appendix B).
- •Able to communicate during the ExAblate BBBD procedure.
- •Able to attend all study visits (i.e., life expectancy of at least 3 months).
Exclusion Criteria
- •The sonication pathway to the tumor involves:
- •i. More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp.
- •ii. Clips or other metallic implanted objects in the skull or the brain, except shunts.
- •The subject presents with symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, and papilledema).
- •Patients with cerebellar or brainstem tumors.
- •Patient receiving bevacizumab (Avastin) therapy.
- •Patients receiving treatment with corticosteroid doses greater than dexamethasone 16mg daily (or equivalent).
- •Patients undergoing other concurrent therapies such as chemotherapy wafers, immunotoxins delivered by convection-enhanced delivery, regionally administered gene and viral therapies, immunotherapies, focal irradiation with brachytherapy, stereotactic radiosurgery, laser interstitial thermotherapy, and tumor treatment fields therapy. These regimens have been shown to cause contrast enhancement in the resection cavity boundary, which can be difficult to differentiate from true tumor recurrence \[35\] \[36\], \[37-39\].
- •Cardiac disease or unstable hemodynamics including:
- •i. Documented myocardial infarction within six months of enrollment. ii. Unstable angina on medication. iii. Congestive heart failure. iv. Left ventricular ejection fraction \<50%. v. History of a hemodynamically unstable cardiac arrhythmia. vi. Cardiac pacemaker.
Outcomes
Primary Outcomes
Adverse Events Safety Profile
Time Frame: 7 months
The type and severity of adverse events post-procedure will be assessed for overall safety. Safety of the BBBD procedure will be evaluated through patient examination and MRI assessments during the treatment and by their standard of care follow-up MRI scans and clinical visits. The standard of care follow-up MRI scans will be used to continue safety monitoring post-BBBD procedures and after adjuvant TMZ chemotherapy is completed.
Secondary Outcomes
- Blood Brain Barrier Opening(7 months)