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Procedure
NanoKnife IRE for Pancreatic Cancer
N/A
Waitlist Available
Led By Cherif Boutros, MD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Receive non-conventional fractionation schedules, such as stereotactic radiation (5 fractions or less) or received higher than 54 Gray (Gy) delivered conventionally
Inability to stop antiplatelet and coumadin therapy for 7 days prior to and 7 days post treatment with the NanoKnife System
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the use of the NanoKnife to treat pancreatic cancer. The study will assess the safety and effectiveness of the NanoKnife and its ability to improve quality of life for patients with pancreatic cancer.
Who is the study for?
Adults with advanced pancreatic cancer that can't be removed surgically and who have finished standard chemo or radiotherapy at least 5 weeks prior. They must understand and agree to the study's process, not be pregnant or breastfeeding, use contraception if of childbearing potential, have no severe lab value abnormalities, no recent heart attacks or certain heart conditions, and not on specific medications.
What is being tested?
The trial is testing the NanoKnife IRE System for treating unresectable pancreatic cancer. This FDA-approved device aims to ablate soft tissue tumors through a minimally invasive procedure which may alleviate symptoms like pain without radical surgery.
What are the potential side effects?
While specific side effects are not listed here, procedures like IRE could potentially cause abdominal pain, infection risk at the electrode sites, bleeding complications due to needle insertion into the pancreas area, and possible damage to nearby organs or structures.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have received a specific type of radiation therapy in 5 or fewer sessions or more than 54 Gray.
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I cannot stop taking my blood thinners for 7 days before and after using the NanoKnife.
Select...
My tumor cannot be measured.
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I am a woman who can have children and am not using birth control.
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I am not pregnant or breastfeeding.
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I cannot be treated with certain muscle relaxants.
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My cancer has spread to distant parts of my body.
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I have a history of epilepsy or irregular heartbeats.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: NanoKnife IRE SystemExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
711 Previous Clinical Trials
379,235 Total Patients Enrolled
Cherif Boutros, MDPrincipal Investigator - University of Maryland, Baltimore
University Of Alexandria (Medical School)
Atlantic Hlth System (Residency)
1 Previous Clinical Trials
25 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a heart attack in the last 2 months.Your heart's Q-T intervals are longer than 550 milliseconds, unless you are using a specific device to control the NanoKnife system's pulses.I have received a specific type of radiation therapy in 5 or fewer sessions or more than 54 Gray.I am 18 years old or older.Your blood clotting test (INR) should be below 1.5.My cancer can't be removed with surgery and hasn't been treated in the last 5 weeks.I haven't taken chemotherapy within 5 weeks before NanoKnife treatment.I cannot stop taking my blood thinners for 7 days before and after using the NanoKnife.My tumor cannot be measured.I am a woman who can have children and am not using birth control.You are very allergic to the metal in the electrodes, and there is no way to treat this allergy.I am not pregnant or breastfeeding.Your baseline creatinine level is higher than 2.0 mg/dL.Your lab test results show severe toxicity.You have a metal implant near the area being studied.You have a history of allergic reaction to contrast dye that cannot be treated by a doctor.I cannot be treated with certain muscle relaxants.My cancer has spread to distant parts of my body.I have a history of epilepsy or irregular heartbeats.
Research Study Groups:
This trial has the following groups:- Group 1: NanoKnife IRE System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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