NanoKnife IRE for Pancreatic Cancer

Overseen By McKenzie Bedra, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Must not be taking: Antiplatelets, Coumadin, Chemotherapy, others

Disqualifiers: Pregnancy, Epilepsy, Cardiac arrhythmia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating pancreatic cancer that cannot be surgically removed. The study uses the NanoKnife IRE System, a device that delivers electrical pulses to target and destroy cancer cells, aiming to reduce symptoms such as pain and jaundice. The trial seeks participants with pancreatic cancer that has not spread after standard treatments like chemotherapy or radiation. Participants must be able to pause certain medications temporarily and comprehend the trial's requirements. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options that could enhance quality of life.

Will I have to stop taking my current medications?

The trial requires participants to stop taking antiplatelet and coumadin therapy for 7 days before and after treatment with the NanoKnife System. Additionally, participants must not have taken any chemotherapy or radiotherapy within 5 weeks of treatment.

What prior data suggests that the NanoKnife IRE System is safe for treating pancreatic cancer?

Research has shown that the NanoKnife Irreversible Electroporation (IRE) System is generally safe for humans. In past studies, patients with inoperable pancreatic cancer experienced some side effects from the NanoKnife IRE System, with bleeding being the most common. However, the treatment is usually well-tolerated when the procedure is carefully managed and the electrical pulses are timed with the heart's rhythm to reduce risks.

The FDA has approved the NanoKnife System for removing soft tissue tumors, indicating a certain level of safety. However, it is not yet FDA-approved specifically for pancreatic cancer. While it appears promising, more studies are needed to confirm its safety and effectiveness for this particular condition. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for pancreatic cancer, such as surgery, chemotherapy, and radiation, the NanoKnife IRE System uses a process called irreversible electroporation. This technique involves delivering electric pulses to the tumor, which creates tiny holes in the cancer cell membranes, leading to cell death without damaging surrounding healthy tissue. Researchers are excited because this method offers a minimally invasive alternative with the potential for fewer side effects and quicker recovery times. Additionally, NanoKnife IRE could be a viable option for tumors that are considered inoperable, providing hope for patients with limited treatment choices.

What evidence suggests that the NanoKnife IRE System is effective for treating unresectable pancreatic cancer?

Studies have shown that the NanoKnife System can benefit patients with pancreatic cancer, particularly when surgery isn't an option. Research indicates that the NanoKnife uses electrical pulses to create tiny holes in cancer cells, leading to their destruction. Early results suggest this method can shrink tumors and alleviate symptoms like pain and jaundice. An observational study found the NanoKnife System safe and effective for treating Stage 3 pancreatic cancer. Although the FDA hasn't specifically approved it for certain conditions, it shows promise for treating pancreatic cancer that can't be surgically removed. Participants in this trial will receive the NanoKnife IRE System as the experimental treatment under study. ^{1 2 6 7 8}

Who Is on the Research Team?

Cherif Boutros, MD

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Are willing and able to comply with the protocol requirements

Are able to comprehend and willing to sign an informed consent form

Your blood clotting test (INR) should be below 1.5.

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ablation of locally advanced unresectable pancreatic cancer using the NanoKnife Irreversible Electroporation (IRE) System

1 day

1 visit (in-person, under general anesthesia)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• NanoKnife IRE System

Trial Overview 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.

How Is the Trial Designed?

Group I: NanoKnife IRE System Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Published Research Related to This Trial

Irreversible electroporation (IRE) is a promising non-thermal treatment for liver metastases from pancreatic cancer, as demonstrated in a case where a 66-year-old patient achieved a complete response after IRE combined with arterial infusion chemotherapy and tegafur.

The patient has survived for over 12 months following this treatment, suggesting that the combination therapy may be effective and could serve as a potential reference for similar cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irreversible electroporation for liver metastasis from pancreatic cancer: A case report. Ma, YY., Shi, JJ., Chen, JB., et al.[2020]

The NanoKnife Low Energy Direct Current (IRE) System was evaluated in a study of 10 patients with unresectable pancreatic cancer, showing a 10% rate of procedure-related complications, indicating it is a relatively safe treatment option.

Despite some early disease progression in a few patients, the overall survival rate was 7.5 months, suggesting that IRE may provide a new avenue for managing this challenging condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and feasibility of Irreversible Electroporation (IRE) in patients with locally advanced pancreatic cancer: results of a prospective study. Paiella, S., Butturini, G., Frigerio, I., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11640091/

Initial Results from the DIRECT Registry Study - PMC The DIRECT Registry study is a prospective trial of irreversible electroporation (IRE) using the NanoKnife System for the treatment of patients with Stage 3 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06937996

Outcomes of Ablation of Unresectable Pancreatic Cancer ... The purpose of this study is to evaluate the short and intermediate term safety of the NanoKnife Irreversible Electroporation System when used off-label to ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10002122/

Irreversible Electroporation in Pancreatic Cancer—An ... M1 virus monotherapy reduced the survival of cancer cells to about 60%, and with the addition of electroporation, the survival rate was only 10% ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03899649

A Registry Study of NanoKnife IRE for Stage 3 Pancreatic ... This multicenter, observational study will evaluate the effectiveness and safety of the NanoKnife System when used for the ablation of Stage 3 pancreatic ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2016-00337

NanoKnife Irreversible Electroporation System in Treating ... This clinical trial studies how well NanoKnife irreversible electroporation system works in treating patients with pancreatic cancer that has spread.

6. bmcsurg.biomedcentral.com bmcsurg.biomedcentral.com/articles/10.1186/s12893-025-03136-9

Real-world safety of irreversible electroporation therapy for ... Although IRE theoretically offers better vascular protection, bleeding remains the most common adverse event in the treatment of pancreatic ...

7. aetna.com aetna.com/cpb/medical/data/800_899/0828.html

Irreversible Electroporation (NanoKnife) - Medical Clinical ... The authors concluded that IRE appears safe for human clinical use if ECG-synchronized delivery is utilized. They recommended comparative evaluation with ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9688427/

Safety and Efficacy of Irreversible Electroporation in Locally ... IRE can kill tumors completely, with well-demarcated borders and tolerance of the heat-sink effect [6,18]. As a radical ablative therapy, IRE ...