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

Primary Purpose

Pancreatic Adenocarcinoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ExAblate 2100
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Pancreatic Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Stanford Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRgFUS Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Assess Pain Response assessed by the Brief Pain Inventory (BPI)
Reduction in pain level, as measured by: a. a decline in pain score after one week of at least 2 points, or a pain score < 4 out of 10, as assessed by the Brief Pain Inventory. Ablation will be deemed pain reducing if at least five of the ten patients have pain reduction.
Assess Pain Response assessed by morphine equivalent daily dose (MEDD)
Reduction in pain level will be measured by a decline after one week in morphine equivalent daily dose (MEDD) of 25%. Ablation will be deemed pain reducing if at least five of the ten patients have pain reduction.
Evidence of ablation-induced inflammation
Evidence of ablation-induced inflammation, defined as post-ablation increases in histologic and/or blood measures of inflammation markers, as measured by either: an increase in tumor infiltrating CD8+ T cells a decrease in immune suppressive cells (Tregs, macrophages) in the tumor an increase in immune activation signatures (including interferon gamma) in the tumor as measured by RNAseq a change in immune profile in the circulating immune cells (PBMCs) to reflect an activated immune response (e.g. activated T or B cells, reduction in immune suppressive cells or cytokines) Ablation will be deemed inflammation-inducing if at least five of the ten patients show at least a 50% increase in inflammation on at least 2 of the 4 markers

Full Information

First Posted
March 4, 2020
Last Updated
October 25, 2022
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04298242
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 22, 2020 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Adenocarcinoma

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRgFUS Treatment
Arm Type
Experimental
Arm Description
The pancreatic tumor will be ablated with magnetic resonance guided focused ultrasound (MRgFUS).
Intervention Type
Device
Intervention Name(s)
ExAblate 2100
Other Intervention Name(s)
InSightec ExAblate 2100 MRgHIFU system
Intervention Description
A non-invasive thermal ablation device fully integrated with an MR imaging system
Primary Outcome Measure Information:
Title
Measure acceptable ablation percentage
Description
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
Time Frame
Immediately after MRgFUS treatment
Title
Total frequency and severity of adverse events
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Assess Pain Response assessed by the Brief Pain Inventory (BPI)
Description
Reduction in pain level, as measured by: a. a decline in pain score after one week of at least 2 points, or a pain score < 4 out of 10, as assessed by the Brief Pain Inventory. Ablation will be deemed pain reducing if at least five of the ten patients have pain reduction.
Time Frame
Baseline, 1 week, and monthly for 24 months following treatment
Title
Assess Pain Response assessed by morphine equivalent daily dose (MEDD)
Description
Reduction in pain level will be measured by a decline after one week in morphine equivalent daily dose (MEDD) of 25%. Ablation will be deemed pain reducing if at least five of the ten patients have pain reduction.
Time Frame
Baseline, 1 week, and monthly for 24 months following treatment
Title
Evidence of ablation-induced inflammation
Description
Evidence of ablation-induced inflammation, defined as post-ablation increases in histologic and/or blood measures of inflammation markers, as measured by either: an increase in tumor infiltrating CD8+ T cells a decrease in immune suppressive cells (Tregs, macrophages) in the tumor an increase in immune activation signatures (including interferon gamma) in the tumor as measured by RNAseq a change in immune profile in the circulating immune cells (PBMCs) to reflect an activated immune response (e.g. activated T or B cells, reduction in immune suppressive cells or cytokines) Ablation will be deemed inflammation-inducing if at least five of the ten patients show at least a 50% increase in inflammation on at least 2 of the 4 markers
Time Frame
1week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pejman Ghanouni
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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