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| ID | Type | Description | Link |
|---|---|---|---|
| PANC0034 | Other Identifier | OnCore | |
| NCI-2020-13809 | Other Identifier | CTRP |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRgFUS Treatment | Experimental | The pancreatic tumor will be ablated with magnetic resonance guided focused ultrasound (MRgFUS). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ExAblate 2100 | Device | A non-invasive thermal ablation device fully integrated with an MR imaging system |
|
| 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 |
| 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 |
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Inclusion Criteria:
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:
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)
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| Name | Affiliation | Role |
|---|---|---|
| Pejman Ghanouni | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Center | Stanford | California | 94304 | United States |
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| 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:
| 1week |