Magnetic Resonance Guided High Intensity Focused Ultrasound in Advanced Pancreatic Adenocarcinoma Treatment
NCT ID: NCT04298242
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1 participants
INTERVENTIONAL
2020-11-22
2021-06-15
Brief Summary
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Detailed Description
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Secondary Objective: 1.)Pain reduction after ablation. 2.) Evidence of inflammation at ablation site based on histology, or in blood after ablation
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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MRgFUS Treatment
The pancreatic tumor will be ablated with magnetic resonance guided focused ultrasound (MRgFUS).
ExAblate 2100
A non-invasive thermal ablation device fully integrated with an MR imaging system
Interventions
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ExAblate 2100
A non-invasive thermal ablation device fully integrated with an MR imaging system
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Principal Investigators
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Pejman Ghanouni
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford Cancer Center
Stanford, California, United States
Countries
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Other Identifiers
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PANC0034
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2020-13809
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-52567
Identifier Type: -
Identifier Source: org_study_id