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

Not Recruiting

Trial ID: NCT04298242


The primary purpose of this protocol is to assess the ExAblate 2100 MR guided high intensity focused ultrasound device as an intervention for treatment of advanced stage pancreatic adenocarcinoma.

Official Title

A Phase I Study of Magnetic Resonance Guided High Intensity Focused Ultrasound for Treatment of Advanced Pancreatic Adenocarcinoma

Stanford Investigator(s)

Pejman Ghanouni, MD, PhD
Pejman Ghanouni, MD, PhD

Associate Professor of Radiology (General Radiology) and, by courtesy, of Neurosurgery, of Obstetrics and Gynecology and of Urology


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

      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)


device: ExAblate 2100

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Risa Jiron

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