NCT03257150

A Study of the Use of Irreversible Electroporation in Pancreatic Ductal Cancer

Irreversible Electroporation for Locally Advanced Pancreatic Ductal Adenocarcinoma (LEAP TRIAL): A Phase I/II Prospective Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This I/II study will evaluate to see how safe and useful irreversible electroporation (also called NanoKnife) is in patients with locally advanced pancreatic cancer.

Detailed description

In this phase I/II trial, patients with locally advanced pancreatic ductal carcinoma will be assigned to receive interventional treatment of irreversible electroporation (IRE). IRE will be performed by laparotomy under general anesthesia in the operating room. All patients enrolled in the study will have a biopsy at the time of laparotomy. Blood will be collected for regular blood tests and correlative studies at baseline and during the study. Computed tomography (CT) scans will be done at baseline, 4 weeks post treatment, 12 weeks, 24 weeks, and 36 weeks follow up. Quality of Life (QOL) questionnaires will be completed at baseline and during the study. Patients will be given optional consent for storage of any leftover tissue and blood samples for future analysis. Patients will be followed up 4 weeks post treatment, then every 12 weeks until death.

Conditions

• Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
PROCEDURE	Irreversible Electroporation	Irreversible electroporation (IRE) is a process that uses the NanoKnife system to sent electrical currents to a cancer tumor which will disrupt the tumor cell and therefore causing the cell to die. Eligible patients will undergo in situ IRE performed via laparotomy surgery.
DEVICE	NanoKnife System	A system consisting of electrode probes connected to a machine. The probes will be surgically placed around the tumor.

Timeline

• Start date: 2017-09-22
• Primary completion: 2022-07-14
• Completion: 2022-07-14
• First posted: 2017-08-22
• Last updated: 2022-08-11

Locations

1 site across 1 country: Canada