Clinical Trial Details
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NCT01473485 : ExAblate (Magnetic Resonance-guided Focused Ultrasound Surgery) Treatment of Brain Tumors
AgesMin: 18 Years Max: 75 Years
Inclusion Criteria:

1. Men or women.

2. Age between 18 and 75 years, inclusive.

3. Able and willing to give informed consent.

4. Able to tolerate pre / post - procedure steroid treatment

5. 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.

6. 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.

7. Tumor(s) are clearly defined on pre-therapy contrast enhanced MRI scans.

- No more than 1 Brain Met can be treated under this protocol

8. 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

9. Karnofsky rating 70-100.

10. ASA score 1-3.

11. Able to communicate sensations during the ExAblate MRGFUS procedure.

12. Able to attend all study visits (i.e., life expectancy of at least 3 months).

13. At least 14 days passed since last brain surgery or radiation therapy.

Exclusion Criteria:

1. The tumor's not visible on the pre-therapy imaging

2. 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

3. 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

4. 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).

5. Anti-coagulant therapy, on medications known to increase risk of hemorrhage, (e.g.:
non-steroidal anti-inflammatory drugs (NSAIDs), statins)

6. Patients with history of bleeding disorder or with history of spontaneous haemorrhage

7. Abnormal level of platelets (< 100000), PT (>14) or PTT (>36), and INR > 1.3.

8. Documented cerebral infarction within past 12 months

9. TIA or stroke in the last 1 month.

10. 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

11. Insulin-dependent diabetes mellitus.

12. Patients taking immunosuppressants (corticosteroids to prevent/treat brain edema are

13. Known sensitivity to gadolinium-DTPA.
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