Glioblastoma, Glioma, Malignant
Conditions
Keywords
Glioma, MRgFUS, Exablate, TMZ
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 high grade glioma undergoing standard of care therapy.
Detailed description
The primary objective is to evaluate the safety and feasibility of BBB disruption using the Exablate Type 2.0 system in adult patients with glioblastoma (GBM) undergoing adjuvant TMZ chemotherapy, which occurs following maximal safe surgical resection and completion of the initial concurrent radiation-chemotherapy in accordance with the current standard of care
Interventions
DEVICEMagnetic Resonance guided Focused ultrasound (MRgFUS)
FUS involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct body targets.
Sponsors
InSightec
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patient is eligible for adjuvant TMZ treatment. 2. Men or women age between 18 and 80 years, inclusive. 3. Able and willing to give informed consent. 4. Grade IV glioma (GBM) confirmed Subjects 5. Karnofsky rating 70-100. 6. Able to communicate during the Exablate BBBD procedure. 7. Life expectancy of at least 3 months.
Exclusion criteria
1. Evidence of acute intracranial hemorrhage. 2. The subject presents with severe symptoms and signs of increased intracranial pressure 3. Patients with cerebellar or brainstem tumors. 4. Patients with positive HIV status 5. Patients with brain tumors containing 1p/19q chromosomal co-deletion 6. Patient receiving bevacizumab (Avastin) therapy 7. Patients undergoing other concurrent therapies 8. Cardiac disease or unstable hemodynamics 9. Severe hypertension 10. Anti-coagulant therapy, or medications known to increase risk of hemorrhage within washout period prior to treatment 11. History of a bleeding disorder and/or coagulopathy 12. Known sensitivity to gadolinium-based contrast agents 13. Known sensitivity to ultrasound contrast agent 14. Severely impaired renal function 15. Subjects with significant liver dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device and procedure related adverse events | 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 |
| Feasibility of repeated BBB disruption will be evaluated through assessment of post-procedure contrast-enhanced magnetic resonance (MR) imaging | At the time of each ExAblate MRgFUS procedure] | The repeatability of BBB disruption will be evaluated at each of the 6 procedures and will be evaluated through assessment of post-procedure contrast-enhanced MR imaging. |
Countries
Italy, Spain
Outcome results
None listed