Clinical trial NCT04298242: Magnetic Resonance Guided High Intensity Focused Ultrasound in Advanced Pancreatic Adenocarcinoma Treatment
Official title: A Phase I Study of Magnetic Resonance Guided High Intensity Focused Ultrasound for Treatment of Advanced Pancreatic Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Adenocarcinoma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

Detailed 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

Eligibility criteria: 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)

Primary outcomes:
measure: Measure acceptable ablation percentage
timeFrame: Immediately after MRgFUS treatment
measure: Total frequency and severity of adverse events
timeFrame: 24 months
Secondary outcomes:
measure: Assess Pain Response assessed by the Brief Pain Inventory (BPI)
timeFrame: Baseline, 1 week, and monthly for 24 months following treatment
measure: Assess Pain Response assessed by morphine equivalent daily dose (MEDD)
timeFrame: Baseline, 1 week, and monthly for 24 months following treatment
measure: Evidence of ablation-induced inflammation
timeFrame: 1week
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
Study officials:
affiliation: Stanford University
name: Pejman Ghanouni
role: PRINCIPAL_INVESTIGATOR
References: