MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors
Verified February 2016 by InSightec
Information provided by (Responsible Party):
First received: September 2, 2005
Last updated: February 1, 2016
Last verified: February 2016
The purpose of this study is to evaluate the safety of MRI-guided focused ultrasound thermal ablation of brain tumors performed through intact human skull using the ExAblate transcranial system. We will collect data to establish the basic safety of this type of treatment as the basis for later studies that will evaluate its clinical efficacy.
Device: ExAblate transcranial system
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Study to Evaluate the Safety and Feasibility of Transcranial MRI-Guided Focused Ultrasound Surgery in the Treatment of Brain Tumors
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2016 (Final data collection date for primary outcome measure)
Experimental: ExAblate transcranial system
MR Guided Focused Ultrasound
Device: ExAblate transcranial system
MRI-Guided Focused Ultrasound Feasibility Study for Brain
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.
|Ages Eligible for Study:
||18 Years to 70 Years (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00147056
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 2, 2005
||February 1, 2016
||United States: Food and Drug Administration
Keywords provided by InSightec:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 28, 2016
Central Nervous System Neoplasms
Nervous System Neoplasms
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Central Nervous System Diseases
Nervous System Diseases