Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption in GBM Patients

• Conditions: Glioma, Malignant; Glioblastoma
• Interventions: Device: Magnetic Resonance guided Focused ultrasound (MRgFUS)

• Registration Number: NCT04998864
• Lead Sponsor: InSightec

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

Study Timeline

• Study First Submitted: 2020-07-27
• Study First Submitted QC: 2021-08-03
• Study First Posted: 2021-08-10
• Study Start: 2021-08-25
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-15
• Last Update Posted: 2022-01-06
• Primary Completion: 2022-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Focused Ultrasound (FUS) BBB Disruption	Magnetic Resonance guided Focused ultrasound (MRgFUS)	The Exablate Model 4000 Type 2.0 system is intended for use as a tool to induce localized and temporary blood-brain barrier disruption in patients with glioblastoma undergoing standard of care chemotherapy.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Fondazione IRCCS Neurologico Carlo Besta; 🇮🇹 Milano, Italy

CINAC-Hospital HM Puerta del Sur; 🇪🇸 Móstoles, Madrid, Spain