Magnetic Resonance Guided High Intensity Focused Ultrasound in Advanced Pancreatic Adenocarcinoma Treatment
Trial ID or NCT#
NCT04298242
Status
NOT RECRUITING
Purpose
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
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
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)
Investigator(s)
Pejman Ghanouni, MD, PhD
Radiologist
Associate Professor of Radiology (Body MRI) and, by courtesy, of Neurosurgery, of Obstetrics and Gynecology and of Urology
Contact us to find out if this trial is right for you.
Contact
Risa Jiron
650-736-1598
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