Feasibility of ExAblate MRI Guided High Intensity Focused Ultrasound Tx of Soft Tissue Tumors

INCLUSION CRITERIA

   - ≥ 10 years of age.

   - Benign or malignant soft tissue tumors of the extremities, flanks, pelvis, or
   shoulders requiring surgical intervention.

   - Tumor must not have been treated previously with radiation.

   - Targeted tumor(s) are accessible to the ExAblate device

   - Targeted volume within the tumor is located deeper than 1 cm from the skin

   - Targeted tumor is clearly visible by non-contrast magnetic resonance imaging (MRI)

   - Karnofsky Performance Status > 60

   - Normal platelet count and coagulation profile

   - Glomerular filtration rate > 60 mL/min

   - Able to safely undergo MRI exam and receive mild sedation for the treatment.

   - Able to tolerate being in the MRI scanner for the duration of the study.

   - Able and willing to give consent (or consent + assent where applicable), and able to
   attend all study visits.

EXCLUSION CRITERIA

   - Previous radiation treatment to the tumor.

   - Currently receiving dialysis.

   - Acute medical condition (eg, pneumonia, sepsis) expected to hinder completion of the
   study

   - Unstable cardiac status including:

      - Unstable angina pectoris on medication

      - Patients with documented myocardial infarction within six months of protocol
      entry

      - Congestive heart failure requiring medication (other than diuretic)

      - Patients on anti-arrhythmic drugs

   - Severe hypertension (diastolic BP > 100 on medication)

   - Contraindication for MR imaging such as implanted metallic devices that are not
   MRI-safe, size limitations, etc

   - Severe hematologic, neurologic, or other uncontrolled disease

   - Known intolerance or allergy to medications used for sedation (midazolam), analgesia
   (fentanyl), and local and regional anesthesia (lidocaine, bupivacaine, and
   ropivacaine)

   - Known intolerance or allergy to MR contrast agent (gadolinium chelates) including
   advanced kidney disease

   - Pregnant and nursing

   - Karnofsky Performance Score < 60

   - Severe cerebrovascular disease [cardiovascular accident (CVA) within 6 months]

   - Not able or not willing to tolerate the required prolonged stationary position during
   treatment (up to 5 hrs of total table time)

   - Target volume in tumor is less than 1 cm from neurovascular bundles, major blood
   vessels, bowel, or bladder.

   - Targeted tumors:

      - NOT visible by non-contrast MRI, OR

      - NOT accessible to ExAblate device

   - Not a candidate for either regional anesthesia or mild sedation

   - Not be participating in another trial testing other investigational agents or devices