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

Glioblastoma Clinical Trial

Official title:

Assessment of Safety and Feasibility of Exablate Blood-Brain Barrier Disruption for the Treatment of High-Grade Glioma in Patients Undergoing Standard Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04998864
• Other study ID #: BT008E
• Status: Recruiting
• Start date: August 25, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: December 2021
• Source: InSightec
• Contact: Nadir Alikacem
• Phone: +1 214-630-2000
• Email: NadirA[@]insightec.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioma
• Glioma, Malignant

Intervention

Device:
• Magnetic Resonance guided Focused ultrasound (MRgFUS)
FUS involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct body targets.

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Neurologico Carlo Besta	Milano
Spain	CINAC-Hospital HM Puerta del Sur	Móstoles	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
InSightec

Countries where clinical trial is conducted

Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device and procedure related adverse events	The number and severity of device and BBB disruption procedure related adverse events will be evaluated and classified according to the CTCAE	Throughout the study, approximately 12 months.
Primary	Feasibility of repeated BBB disruption will be evaluated through assessment of post-procedure contrast-enhanced magnetic resonance (MR) imaging	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.	At the time of each ExAblate MRgFUS procedure]