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

NCT04298242 | Completed DMC FDA Device

• 3 other identifiers: IRB-52567PANC0034NCI-2020-13809
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Measure acceptable ablation percentage

  Feasibility of ablation, as measured by the number of patients with acceptable ablation percentage. Acceptable ablation percentage is defined as ≥50% of the targeted volume appearing ablated on post-treatment imaging. Ablation will be deemed feasible if at least seven of the ten patients have an acceptable ablation percentage

  Immediately after MRgFUS treatment

• Total frequency and severity of adverse events

  Safety of ablation, as measured by the total frequency and severity of adverse events. Adverse events will be categorized and grade for severity according to the Common Terminology Criteria for Adverse Events, Version 5.0. Ablation will be deemed safe if there are no treatment-related serious adverse events, and no more than five moderate or mild treatment-related adverse events, among the ten patients during follow up.

  24 months

Secondary Outcomes (3)

• Assess Pain Response assessed by the Brief Pain Inventory (BPI)

  Baseline, 1 week, and monthly for 24 months following treatment

• Assess Pain Response assessed by morphine equivalent daily dose (MEDD)

  Baseline, 1 week, and monthly for 24 months following treatment

• Evidence of ablation-induced inflammation

  1week

Study Arms (1)

MRgFUS Treatment

EXPERIMENTAL

The pancreatic tumor will be ablated with magnetic resonance guided focused ultrasound (MRgFUS).

Device: ExAblate 2100

Interventions

ExAblate 2100 DEVICE

A non-invasive thermal ablation device fully integrated with an MR imaging system

Also known as: InSightec ExAblate 2100 MRgHIFU system

MRgFUS Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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:
• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Cancer Center

Stanford, California, 94304, United States

Location

Study Officials

• Pejman Ghanouni

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 6, 2020
• Study Start: November 22, 2020
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)