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GliomaNCT01473485

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

A study testing ExAblate Transcranial System in people with Glioma and Metastatic Brain Cancer, run by InSightec at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Glioma, Metastatic Brain Cancer
What is being tested?
ExAblate Transcranial System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteCanada
Study dates
Apr 2011to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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.
  • Cardiac pacemaker.
  • Severe hypertension (diastolic BP > 100 on medication).
  • Anti-coagulant therapy, on medications known to increase risk of hemorrhage, (e.g.: non-steroidal anti-inflammatory drugs (NSAIDs), statins)
  • Patients with history of bleeding disorder or with history of spontaneous haemorrhage tumour
  • Abnormal level of platelets (< 100000), PT (>14) or PTT (>36), and INR > 1.3.
  • Documented cerebral infarction within past 12 months
  • TIA or stroke in the last 1 month.
  • Patients with cerebral or systemic vasculopathy:
  • Symptomatic systemic vascular disease is defined as cardiovascular disease which prevents any procedure in MRI where ECG cannot be obtained (i.e. coronary disease). These patients must be excluded
  • Insulin-dependent diabetes mellitus.
  • Patients taking immunosuppressants (corticosteroids to prevent/treat brain edema are permitted).
  • Known sensitivity to gadolinium-DTPA.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

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

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

Read the detailed description

Although the initial treatment of malignant gliomas is well established, the best treatment for progressive disease remains undefined. Patients with newly diagnosed gliomas are typically treated with surgery followed by conformal radiation and concomitant chemotherapy. Even though these tumors are not curable, prolonged survival can be achieved in selected patients. Despite improved multimodal therapies, almost all of the patients experience recurrence at the site of the primary tumor where they have already received maximal surgical resection and radiation therapy. Typically, these patients have a life expectancy of approximately 6 months, with less than a third of patients alive at one year. Salvage therapy for these patients usually take the form of various systemic chemotherapeutic agents because localized therapies such as reirradiation may not be possible in the previously irradiated site. As progressive disease has very poor response rates to current systemic therapies, efforts to define the role of novel local therapies, such as MR guided focused ultrasound (MRgFUS), is necessary.

There are very few local therapy options for progressive gliomas. Traditionally, reirradiation and surgery are considered last resort treatments for symptomatic recurrence. In the initial treatment of gliomas, the tumor and surrounding brain receive near tolerance doses and usually preclude a second course of radiation therapy. If clinically advisable and feasible, a second operation may be undertaken but is usually reserved for younger patients with a good neurological status who are developing neurological symptoms related to the mass effect of the tumor. The use of MR guided focused ultrasound represents a new, noninvasive therapeutic option that overcomes some of the limitations of secondary surgery or reirradiation and provides the patient with an option for local ablative therapy. The lesioning of the tumor is done accurately under MRI guidance with real-time monitoring of the ablative ultrasonic hyperthermia. As the cytotoxic affects are due to hyperthermia, there is no cumulative radiation affect which limits the use of radiotherapy in recurrent disease. The potential benefits for the patient include local control of the disease/tumor, and prolonging the time to subsequent salvage therapies.

A similar situation exists for brain metastases. Historically, the development of brain metastases was considered a terminal event, however, with better local therapies as well a systemic therapies, patients are living longer. Initial management of patients with brain metastases usually involves surgery, whole brain radiation, radiosurgery or a combination of these modalities depending on the clinical situation. The goal of treating brain metastases is to prevent the patient from succumbing to CNS disease. As improved systemic therapy has lengthened the survival of patients with metastatic tumors, more patients are surviving and developing recurrent or progressive metastatic CNS disease. Progressive disease usually requires more local therapies as chemotherapeutic agents do not adequately cross the blood brain barrier to have a large impact on CNS metastases. MRIgFUS could play and important role in ablating brain metastases in patients who have already been maximally radiated and are otherwise without options.

Being tested
ExAblate Transcranial System
Keywords
Brain Tumor, Glioma, Brain Cancer, Metastatic Brain Cancer
Medical subject headings
Glioma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExAblate Transcranial SystemDevice

    Also called MRgFUS, FUS, Focused Ultrasound, MR Guided Focused Ultrasound

    MR Guided Focused Ultrasound

Study groups in NCT01473485
Study groupRoleWhat they receive
ExAblate Transcranial DeviceExperimentalNot described
Receives: Device: ExAblate Transcranial System

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: At the time of ExAblate procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01473485
Sponsor's protocol ID
BT003
Status last verified
Apr 2025
First submitted
14 Nov 2011
Last updated
1 May 2025
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing ExAblate Transcranial System in people with Glioma and Metastatic Brain Cancer, run by InSightec at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate Safety of ExAblate Transcranial Device (time frame: At the time of ExAblate procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.

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