Magnetic Resonance Guided High Intensity Focused Ultrasound in Advanced Pancreatic Adenocarcinoma Treatment
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|ClinicalTrials.gov Identifier: NCT04298242|
Recruitment Status : Active, not recruiting
First Posted : March 6, 2020
Last Update Posted : October 26, 2022
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Adenocarcinoma||Device: ExAblate 2100||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||A Phase I Study of Magnetic Resonance Guided High Intensity Focused Ultrasound for Treatment of Advanced Pancreatic Adenocarcinoma|
|Actual Study Start Date :||November 22, 2020|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||November 2024|
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
Other Name: InSightec ExAblate 2100 MRgHIFU system
- Measure acceptable ablation percentage [ Time Frame: Immediately after MRgFUS treatment ]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 [ Time Frame: 24 months ]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.
- Assess Pain Response assessed by the Brief Pain Inventory (BPI) [ Time Frame: Baseline, 1 week, and monthly for 24 months following treatment ]
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) [ Time Frame: Baseline, 1 week, and monthly for 24 months following treatment ]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 [ Time Frame: 1week ]
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04298242
|United States, California|
|Stanford Cancer Center|
|Stanford, California, United States, 94304|
|Principal Investigator:||Pejman Ghanouni||Stanford University|