Magnetic Resonance Guided High Intensity Focused Ultrasound in Advanced Pancreatic Adenocarcinoma Treatment

Inclusion Criteria:

   - Men and women ≥ 18 years of age

   - Patients willing to sign a written informed consent document

   - Patients with unresectable, locally advanced or metastatic pancreatic adenocarcinoma

   - Patients with upper abdominal pain rating at least 4 out of 10 in severity on BPI

   - Tumor must be visualized on CT or MRI, obtained within 30 days of enrollment

   - Tumor must be accessible to the ExAblate MRgFUS device

   - Life expectancy ≥ 3 months, as determined by oncologist and documented in chart

   - ECOG performance status of 0, 1, or 2

   - INR < 1.6, platelet count > 50,000 microL

   - Serum urate, calcium, potassium, phosphate, creatinine < 1.5x upper limit of normal

   - Patients can receive general anesthesia, as determined by anesthesiologist

Exclusion Criteria:

   - Previous pancreatic surgery

   - Patients with contraindication for MR imaging such as implanted metallic devices that
   are not MRI-safe, size limitations, claustrophobia, etc.

   - Patients with known intolerance or allergy to MR contrast agent (gadolinium chelates)
   including advanced kidney disease (GFR <30 mL/min/1.73 m2) or on dialysis

   - Pregnant and nursing patients will be excluded from the study because of a
   contraindication to administering MRI contrast agents to these patients

   - Patients unable to receive general anesthesia

   - Target is:

      1. NOT visible by non-contrast MRI, OR

      2. NOT accessible to ExAblate device

   - Individuals who are not able or willing to tolerate the required prolonged stationary
   position during treatment (can be up to 6 hrs of total table time)

   - Patients with acute medical condition (e.g. pneumonia, sepsis) that is expected to
   hinder them from completing this study

   - Patients with unstable cardiac status including:

      1. Unstable angina pectoris on medication

      2. Patients with documented myocardial infarction within six months of protocol
      entry

      3. Congestive heart failure requiring medication (other than diuretic)

      4. Patients on anti-arrhythmic drugs

      5. Patients with severe hypertension (diastolic BP > 100 on medication)

      6. Patients with severe hematologic, neurologic, or other uncontrolled disease (e.g.
      platelets < 50,000/microL, INR > 1.5)

   - Patients who are taking anti-thrombotic medication

   - Severe cerebrovascular disease (multiple CVAs or CVA within 6 months)