Status:
ACTIVE_NOT_RECRUITING
MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors
Lead Sponsor:
InSightec
Conditions:
Brain Tumor
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 wi...
Detailed Description
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 ove...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00147056
Start Date
August 1 2012
End Date
December 1 2026
Last Update
May 1 2025
Active Locations (2)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Swedish Medical Center
Seattle, Washington, United States, 98122