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

4 Participants Needed

Trial Summary

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 data supports the effectiveness of the NanoKnife IRE treatment for pancreatic cancer?

Research shows that the NanoKnife IRE treatment, a non-thermal method that uses electrical pulses to destroy cancer cells, has been effective in extending survival and achieving complete tumor regression in some cases of pancreatic cancer. In studies, it significantly improved survival rates and led to complete tumor regression in over half of the treated mice. ^{1 2 3 4 5}

How does the NanoKnife IRE treatment for pancreatic cancer differ from other treatments?

The NanoKnife IRE treatment is unique because it uses electrical pulses to create tiny holes in cancer cells, which leads to cell death without the need for traditional surgery or chemotherapy. This method can target tumors precisely and is less invasive, potentially reducing damage to surrounding healthy tissue. ^{6 7 8 9 10}

What is the purpose of this trial?

The purpose of this study is to evaluate the short and intermediate term outcomes of the NanoKnife Irreversible Electroporation System when used to treat unresectable pancreatic cancer. In addition, the study will evaluate the efficacy of this device in treating symptoms of unresectable pancreatic cancer. The NanoKnife, System has been commercially available since 2009, and is FDA-approved to treat soft tissue tumors. The NanoKnife System has received FDA clearance for the surgical ablation of soft tissue. It has not received clearance for the therapy or treatment of any specific disease or condition. Irreversible electroporation (IRE) has the potential to dramatically widen the treatment options for patients with pancreatic cancer. It provides a minimally invasive procedure that could potentially avoid radical surgery for smaller lesions, and it could potentially offer palliation of symptoms such as pain, gastric outlet obstruction and jaundice in patients with locally advanced unresectable disease.

Research Team

Cherif Boutros, MD

Principal Investigator

University of Maryland, Baltimore

Eligibility Criteria

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

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

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

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and feasibility of Irreversible Electroporation (IRE) in patients with locally advanced pancreatic cancer: results of a prospective study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Preliminary clinical application of the robot-assisted CT-guided irreversible electroporation ablation for the treatment of pancreatic head carcinoma. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Irreversible electroporation for liver metastasis from pancreatic cancer: A case report. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Controllable Moderate Heating Enhances the Therapeutic Efficacy of Irreversible Electroporation for Pancreatic Cancer. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluation of resistance as a measure of successful tumor ablation during irreversible electroporation of the pancreas. [2014]

6. United States pubmed.ncbi.nlm.nih.gov

Multiplex Digital Polymerase Chain Reaction on a Droplet Array SlipChip for Analysis of KRAS Mutations in Pancreatic Cancer. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Orthotopic Implantation of Murine Pancreatic Ductal Adenocarcinoma. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Capture, release and culture of circulating tumor cells from pancreatic cancer patients using an enhanced mixing chip. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Novel 3D µtissues Mimicking the Fibrotic Stroma in Pancreatic Cancer to Study Cellular Interactions and Stroma-Modulating Therapeutics. [2021]

10. England pubmed.ncbi.nlm.nih.gov

A magnetic micropore chip for rapid ( [2020]