ExAblate (Magnetic Resonance-guided Focused Ultrasound Surgery) Treatment of Brain Tumors

NCT01473485 | Active Not Recruiting

• 1 other identifier: BT003
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

A Study to Evaluate the Safety and Feasibility of Transcranial MRI-Guided Focused Ultrasound Surgery in the Treatment of Brain Tumors

Conditions

Glioma; Metastatic Brain Cancer

Keywords

Brain Tumor; Glioma; Brain Cancer; Metastatic Brain Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluate Safety of ExAblate Transcranial Device

  To evaluate the incidence and severity of Adverse Events (AEs) associated with the ExAblate Transcrainal device during ExAblate treatment

  At the time of ExAblate procedure

Study Arms (1)

ExAblate Transcranial Device

EXPERIMENTAL

Device: ExAblate Transcranial System

Interventions

ExAblate Transcranial System DEVICE

MR Guided Focused Ultrasound

Also known as: MRgFUS, FUS, Focused Ultrasound, MR Guided Focused Ultrasound

ExAblate Transcranial Device

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women.
• Age between 18 and 75 years, inclusive.
• Able and willing to give informed consent.
• Able to tolerate pre / post - procedure steroid treatment
• Subjects with recurrent or progressive glioma who have failed standard therapy with surgery and/or radiation for whom local therapy has been requested by the neuro-oncologist. This treatment will be offered as an option for those patients where neither surgery or repeat radiotherapy is advised by the multidisciplinary team.
• OR Patients with metastatic brain cancer that has progressed despite prior radiotherapy and local therapy is requested by the oncologist. This treatment will be offered as an option for those patients where surgery is not indicated and discussed with the potential options for repeat radiotherapy or salvage radiosurgery by the multidisciplinary team.
• The targeted tumor tissue is located in the cerebral hemispheres, \> 2.5 cm from the inner table of the skull. Non-targeted parts of the tumor may extend outside the treated tumor limits.
• Tumor(s) are clearly defined on pre-therapy contrast enhanced MRI scans.
• No more than 1 Brain Met can be treated under this protocol
• Size of the targeted portion of the tumor (i.e. prescribed ROT) is less than 2.5 cm in diameter (8 cm3 in volume). The non-targeted tumor tissue may exceed the targeted volume.
• Karnofsky rating 70-100.
• ASA score 1-3.
• Able to communicate sensations during the ExAblate MRGFUS procedure.
• Able to attend all study visits (i.e., life expectancy of at least 3 months).
• At least 14 days passed since last brain surgery or radiation therapy.

You may not qualify if:

• The tumor's not visible on the pre-therapy imaging
• The tumor presenting the following imaging characteristics
• Brain edema and/or mass effect that causes midline shift or shift in wall of the third (3rd) ventricle of more than 10-mm.
• Targeted area (i.e.: ROT) less than 5 millimeters from primary branches of cerebral vessels, dural sinuses, the hypophysis or cranial nerves
• Evidence of recent (less than 2 weeks) intracranial hemorrhage.
• Containing calcifications in the focused ultrasound sonication beam path in the event system tools cannot tailor the treatment around these calcification spots
• The sonication pathway to the tumor involves
• More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp.
• Clips or other metallic implanted objects in the skull or the brain, except shunts.
• The subject presents with:
• Symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, and papilledema).
• Unstable hemodynamic status including:
• Documented myocardial infarction within six months of enrollment.
• Symptomatic coronary artery stenosis.
• Congestive heart disease not controlled by medication.

Sponsors & Collaborators

• InSightec: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Glioma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2011
• First Posted: November 17, 2011
• Study Start: April 1, 2011
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

CA (1)