A Study to Evaluate the Safety and Feasibility of Transcranial MRI-Guided Focused Ultrasound Surgery in the Treatment of Brain Tumors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Brain Tumor
- Sponsor
- InSightec
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Number of subjects with Serious and Non-Serious Adverse Events after MRI Guided Focused ultrasound treatment for brain tumors
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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 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.
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 over a 3-month period with contrast MRI and clinical exams. The objectives are: 1. 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. 2. 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.
Investigators
Eligibility Criteria
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-
- •Able to communicate sensations during the ExAblate MRGFUS procedure.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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.