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

NCT ID: NCT04998864

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-25

Study Completion Date

2023-10-12

Brief Summary

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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

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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

Conditions

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Glioma, Malignant Glioblastoma

Keywords

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Glioma, MRgFUS, Exablate, TMZ

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Focused Ultrasound (FUS) BBB Disruption

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.

Magnetic Resonance guided Focused ultrasound (MRgFUS)

Intervention Type DEVICE

FUS involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct body targets.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Exablate Neuro

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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InSightec

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondazione IRCCS Neurologico Carlo Besta

Milan, , Italy

Site Status

CINAC-Hospital HM Puerta del Sur

Móstoles, Madrid, Spain

Site Status

Countries

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Italy Spain

Other Identifiers

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BT008E

Identifier Type: -

Identifier Source: org_study_id