MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00147056 |
Recruitment Status :
Active, not recruiting
First Posted : September 7, 2005
Last Update Posted : September 8, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Brain Tumor | Device: ExAblate transcranial system | Not Applicable |
In this non-randomized feasibility study, FUS under MRI-guidance and thermometry will be given through intact human skull to brain tumor in up to ten (10) subjects. These subjects will be followed over a 3-month period with contrast MRI and clinical exams.
The objectives are:
- To evaluate the safety of ExAblate TcMRgFUS treatment delivered through intact human skull to the brain, during the treatment, and during the follow-up period of 3 months.
- To evaluate the effect of thermal ablation in the target tumor with contrast MR imaging to identify viable tumor, and non-viable thermally ablated tissue.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Study to Evaluate the Safety and Feasibility of Transcranial MRI-Guided Focused Ultrasound Surgery in the Treatment of Brain Tumors |
Study Start Date : | August 2012 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: ExAblate transcranial system
MR Guided Focused Ultrasound
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Device: ExAblate transcranial system
MRI-Guided Focused Ultrasound Feasibility Study for Brain |
- Number of subjects with Serious and Non-Serious Adverse Events after MRI Guided Focused ultrasound treatment for brain tumors [ Time Frame: Up to 3 months ]To evaluate the safety of ExAblate TcMRgFUS treatment delivered through intact human skull to the brain, during the treatment and during the follow-up period of 3 months.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men or women.
- Age between 18 and 70 years, inclusive.
- Able and willing to give informed consent.
- Subjects with (newly diagnosed or recurrent) metastatic cancer for whom surgery, radiation, or radiosurgery has not been advised by the treating physician.
- 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.
- Size of the targeted portion of the tumor (i.e. prescribed Region Of Treatment) is less than 2.5 cm in diameter or 8 cm3 in volume. The non-targeted tumor tissue may exceed the targeted volume.
- Karnofsky rating 70-100 (See Appendix A).
- ASA score 1-2.
- 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 intracranial radiation therapy/radiosurgery
Exclusion Criteria:
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The subject presents with:
- Symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, and papaedema).
- Unstable hemodynamic status including: i. Documented myocardial infarction within six months of enrollment. ii.Symptomatic coronary artery stenosis. iii. Congestive heart disease requiring medication. iv. Anti-arrhythmic drug medication. v. Cardiac pacemaker. vi. 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
- TIA or stroke in the last 1 month
- Insulin-dependent diabetes mellitus
- Immunosuppression (corticosteroids to prevent brain edema are permitted)
- Known sensitivity to gadolinium-DTPA
- Contraindications to MRI such as non-MRI-compatible implanted devices
- Large subjects not fitting comfortably into the MRI scanner
- Difficulty laying supine and still for up to 4 hours in the MRI unit or claustrophobia
- Untreated, uncontrolled Sleep apnea
- Positive pregnancy test (for pre-menopausal women)
- Known life-threatening systemic disease
- More than 3 metastatic tumors
- History of abnormal bleeding and coagulopathy
- Use of Avastin in the preceding two weeks or planned use in the forthcoming two weeks and VEGF inhibitors within + 30 days of treatment
- Patients with a history of uncontrolled seizures or who are not on anti seizure medication (e.g., Phenytoin 100 mg PO t.i.d. or Keppra 500 mg po bid) before the procedure

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00147056
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 | |
United States, Washington | |
Swedish Medical Center | |
Seattle, Washington, United States, 98122 |
Responsible Party: | InSightec |
ClinicalTrials.gov Identifier: | NCT00147056 |
Other Study ID Numbers: |
BT002 |
First Posted: | September 7, 2005 Key Record Dates |
Last Update Posted: | September 8, 2021 |
Last Verified: | August 2021 |
Brain tumor Brain Lesions Brain Cancer ExAblate |
Brain Neoplasms Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms |
Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases |