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

  • STATUS
    Recruiting
  • End date
    Nov 13, 2024
  • participants needed
    10
  • sponsor
    Stanford University
Updated on 13 May 2022

Summary

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.

Description

Primary Objective: The primary endpoints for this study will be 1) feasibility of ablation and 2) safety of ablation.

Secondary Objective: 1.)Pain reduction after ablation. 2.) Evidence of inflammation at ablation site based on histology, or in blood after ablation

Details
Condition Pancreatic Adenocarcinoma
Treatment ExAblate 2100
Clinical Study IdentifierNCT04298242
SponsorStanford University
Last Modified on13 May 2022

Eligibility

Yes No Not Sure

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
NOT visible by non-contrast MRI, OR
NOT accessible to ExAblate device
Individuals who are not able or willing to tolerate the required prolonged stationary
Patients with acute medical condition (e.g. pneumonia, sepsis) that is expected to hinder them from completing this study
position during treatment (can be up to 6 hrs of total table time)
Patients with 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
Patients with severe hypertension (diastolic BP > 100 on medication)
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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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