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

Study Overview

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

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.

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

Pancreatic Adenocarcinoma

DEVICE: ExAblate 2100

IRB-52567
PANC0034 (OTHER Identifier) (OTHER: OnCore)
NCI-2020-13809 (OTHER Identifier) (OTHER: CTRP)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-03-04	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-11-21
First Submitted that Met QC Criteria 2020-03-04	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-11-22
First Posted (ACTUAL) 2020-03-06	Results First Posted N/A	Last Verified 2023-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Device Feasibility

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: MRgFUS Treatment The pancreatic tumor will be ablated with magnetic resonance guided focused ultrasound (MRgFUS).	DEVICE: ExAblate 2100 A non-invasive thermal ablation device fully integrated with an MR imaging system

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: MRgFUS Treatment

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

DEVICE: ExAblate 2100

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

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
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.	Baseline, 1 week, and monthly for 24 months following treatment
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.	Baseline, 1 week, and monthly for 24 months following treatment
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: 1. an increase in tumor infiltrating CD8+ T cells 2. a decrease in immune suppressive cells (Tregs, macrophages) in the tumor 3. an increase in immune activation signatures (including interferon gamma) in the tumor as measured by RNAseq 4. 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	1week

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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:

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:

Patients who are taking anti-thrombotic medication
Severe cerebrovascular disease (multiple CVAs or CVA within 6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Pejman Ghanouni, Stanford University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record