Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier Disruption for the Treatment of High Grade Glioma in Patients Undergoing Standard Chemotherapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Glioblastoma
- Sponsor
- InSightec
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Device and procedure related adverse events
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety of blood-brain barrier (BBB) disruption in adult patients with a first presentation of a glioblastoma (GBM) following a maximal safe surgical resection and standard chemo-radiation with temozolomide (TMZ) protocol and ready for the maintenance phase of the Stupp protocol with TMZ.
Detailed Description
This is a prospective, single center, single-arm study to establish the safety, feasibility, and effectiveness of BBB disruption along the periphery of the tumor resection cavity using the ExAblate Neuro Model 4000 Type 2 (220 kHz) system and DEFINITY ultrasound contrast in patients with GBM. Adult patients with a first time diagnosis of GBM, whom have undergone maximal safe surgical resection and have safely completed the initial phase of concurrent chemo-radiation therapy, will be recruited for this study. Twenty patients will undergo up to 6 treatments with FUS coincident with their standard TMZ cycles.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men or women.
- •Age between 18 and 80 years, inclusive.
- •Able and willing to give informed consent.
- •Grade IV malignant glioma (GBM) confirmed through assessment of surgical specimens by a board-certified neuropathologist.
- •Undergone maximal safe surgical resection and completed concurrent radiotherapy+oral TMZ without any complications and deemed eligible for the maintenance phase of TMZ treatment.
- •Karnofsky rating 70-
- •ASA score 1-
- •Able to communicate during the ExAblate MRgFUS procedure.
- •Able to attend all study visits (i.e., life expectancy of at least 3 months).
Exclusion Criteria
- •Patients presenting with the following imaging characteristics:
- •i. Evidence of recent intracranial hemorrhage.
- •The sonication pathway to the tumour involves:
- •i. Extensive scalp scars, ii. Clips or other metallic implanted objects in the skull or the brain (brain implants).
- •The subject presents with symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, and papilledema).
- •Patients requiring increasing doses of corticosteroids.
- •Patient receiving bevacizumab (Avastin) therapy.
- •Patients undergoing other concurrent therapies such as chemotherapy wafers, immunotoxins delivered by convection-enhanced delivery, regionally administered gene and viral therapies, immunotherapies, and focal irradiation with brachytherapy, stereotactic radiosurgery, and laser interstitial thermotherapy.
- •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
Device and procedure related adverse events
Time Frame: Throughout the study, approximately 12 months.
The number and severity of device and BBB disruption procedure related adverse events will be evaluated and classified according to the CTCAE
Secondary Outcomes
- Effectiveness of BBB disruption in the treated tumor region(at each standard of care neuro-oncology follow up visit until date of death from any cause, assessed up to 48 months)
- Feasibility of repeated BBB disruption will be evaluated through assessment of post-procedure contrast-enhanced magnetic resonance (MR) imaging(Immediately after each FUS BBB disruption procedure)