Magnetic Resonance Guided High Intensity Focused Ultrasound in Advanced Pancreatic Adenocarcinoma Treatment
Trial ID or NCT#
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.
A Phase I Study of Magnetic Resonance Guided High Intensity Focused Ultrasound for Treatment of Advanced Pancreatic Adenocarcinoma
- - 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
- - 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)
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