500 Participants Needed

Irreversible Electroporation for Pancreatic Cancer

Recruiting at 16 trial locations
RM
Overseen ByRobert Martin, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Louisville
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to better understand how Irreversible Electroporation (IRE) can assist people with pancreatic cancer when surgery isn't an option. Researchers seek to determine the optimal timing and application of this treatment, as well as potential challenges or side effects. Suitable candidates for this trial have pancreatic cancer and receive a recommendation from their doctor for soft tissue ablation, which targets the cancer without traditional surgery. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in cancer care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that pancreatic irreversible electroporation (IRE) is safe for treating pancreatic cancer?

Research has shown that pancreatic irreversible electroporation (IRE) can cause moderate side effects. One study found that about 25% of patients experienced adverse reactions, such as post-procedure pain and pancreatitis, which is inflammation of the pancreas. However, since IRE does not use heat or cold, it is less likely to damage nearby healthy tissues compared to other treatments.

Another study indicated that IRE can be safely combined with standard chemotherapy for treating pancreatic cancer. While some risks exist, many patients tolerate the treatment well when used alongside other cancer therapies.12345

Why are researchers excited about this trial?

Researchers are excited about Pancreatic Irreversible Electroporation (IRE) because it offers a unique approach to treating pancreatic cancer. Unlike traditional treatments such as surgery, chemotherapy, or radiation, IRE uses electrical pulses to target and destroy cancer cells without damaging surrounding healthy tissue. This precision could mean fewer side effects and potentially better outcomes for patients. Additionally, IRE may be an option for tumors that are considered inoperable, providing hope for patients with limited treatment options.

What evidence suggests that pancreatic IRE is effective for pancreatic cancer?

Research has shown that Pancreatic Irreversible Electroporation (IRE) is a promising treatment for pancreatic cancer, particularly for tumors that cannot be surgically removed. Studies have found that IRE uses electrical pulses to effectively target and destroy cancer cells, helping to shrink or eliminate tumors with clear edges. For patients with locally advanced pancreatic cancer, IRE has improved survival rates, offering an important option when traditional surgeries are not possible. Additionally, IRE is well-tolerated and does not use heat, making it a safer choice for treating tumors near sensitive areas. This evidence supports the potential of IRE as a valuable tool in treating challenging pancreatic cancers.678910

Who Is on the Research Team?

RM

Robert Martin, MD, PhD

Principal Investigator

University of Louisville

Are You a Good Fit for This Trial?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo pancreatic irreversible electroporation (IRE) treatment for unresectable soft tissue pancreatic tumors

Varies per patient

Follow-up

Participants are monitored for safety, effectiveness, and adverse events after treatment

Up to 2 years
Every 3-4 months for the first year, every 6 months for the second year

Long-term follow-up

Capture overall survival and long-term adverse events in patients treated with IRE

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Pancreatic Irreversible Electroporation (IRE)

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials
353
Recruited
76,400+

The Americas Hepato-Pancreato-Biliary Association

Collaborator

Trials
1
Recruited
500+

Citations

Irreversible electroporation for the management of pancreatic ...Studies showed that IRE was a viable treatment for locally advanced pancreatic cancer or borderline resectable pancreatic cancer because it allowed tumor ...
Effectiveness and safety of irreversible electroporation ...Background: Outcomes for patients with Stage 3 pancreatic ductal adenocarcinoma (PDAC) remain poor with a mean overall survival (OS) of 11 ...
Effectiveness and Safety of Irreversible Electroporation ...FOLFIRINOX has demonstrated improved overall survival (OS) to 11.1 months for FOLFIRINOX versus 6.4 months for gemcitabine alone in metastatic pancreatic cancer ...
Irreversible electroporation of the pancreas – A decade onTo date, the 5-year overall survival for patients with pancreatic adenocarcinoma is approximately 8%. Surgical resection with adjuvant chemotherapy is ...
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 ...
Severe complications with irreversible electroporation of ...The complications from IRE in the region of the pancreatic head previously described are moderate and include postprocedural pain, pancreatitis, subcutaneous ...
Multi-institutional review of adverse events associated with ...This study revealed a 25% rate of adverse events associated with irreversible electroporation in locally advanced pancreatic adenocarcinoma.
Percutaneous irreversible electroporation with systemic ...Conclusions: These results suggest that percutaneous IRE ablation of unresectable LAPC is safe to integrate with standard-of-care chemotherapy and may improve ...
Complications of Percutaneous Irreversible Electroporation for ...The thermal ablative techniques cause complications due to heat-induced peripancreatic vasculature, bile duct, and duodenum necro- sis. ...
FAQs about Irreversible Electroporation (IRE) for ...A: IRE does not generate heat or cold, which could damage normal, adjacent tissues. For example, when a pancreatic cancer is deemed inoperable because it ...
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