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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 2, 4, 7, 14, 21 and 30 days and 3, 6, 9, 12, 15, 18, 21, and 24 months post-ire procedure
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1, 2, 4, 7, 14, 21 and 30 days and 3, 6, 9, 12, 15, 18, 21, and 24 months post-ire procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 2, 4, 7, 14, 21 and 30 days and 3, 6, 9, 12, 15, 18, 21, and 24 months post-ire procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Secondary outcome measures
Pain Scores on the Visual Analogue Score (VAS)
Quality of Life on the EORTC QLQ-PAN26 and EORTC QLQ-C30
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
688 Previous Clinical Trials
374,652 Total Patients Enrolled
Cherif Boutros, MDPrincipal Investigator - University of Maryland, Baltimore
University Of Alexandria (Medical School)
Atlantic Hlth System (Residency)
1 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people have been selected to participate in this test phase of the treatment?
"Yes, as shown on clinicaltrials.gov this study is still open to recruitment. It was first posted on April 1st, 2014 with the most recent update being March 25th, 2022. They are only looking for 12 patients at a single site."
Answered by AI
Are there any patients who have yet to be accepted into this research?
"This clinical trial is currently recruiting patients, according to the listing on clinicaltrials.gov. The listing was first posted on April 1, 2014 and was most recently updated on March 25, 2022."
Answered by AI
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