Spots Global Cancer Trial Database for PANFIRE Study: Irreversible Electroporation (IRE) to Treat Locally Advanced Pancreatic Carcinoma
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Trial Identification
Brief Title: PANFIRE Study: Irreversible Electroporation (IRE) to Treat Locally Advanced Pancreatic Carcinoma
Official Title: PANFIRE - Pilot-study: Non-thermal Ablation Using Irreversible Electroporation (IRE) to Treat Locally Advanced Pancreatic Carcinoma - a Phase I Clinical Trial
Study ID: NCT01939665
Interventions
Study Description
Brief Summary: Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels and bile ducts. With IRE, multiple electrical pulses are applied to tumorous tissue. These pulses alter the existing transmembrane potential of the cell membranes, and create 'nanopores', after which the cell dies through loss of homeostasis. The purpose of this study is to investigate the safety of percutaneous IRE in the treatment of patients with locally advanced pancreatic carcinoma (LAPC). Other objectives are feasibility and efficacy of IRE based upon symptomatic response and tumor response. Fourty patients with histologically confirmed locally advanced pancreatic adenocarcinoma (\<5cm) will undergo percutaneous irreversible electroporation of the tumor using CT and ultrasound guidance. After IRE, patients will be carefully monitored and any (serious) adverse events are registered. Follow-up will consist of frequent CT scanning, as well as serum CA19.9 tumor marker. We hypothesize that IRE in the pancreas will induce good symptom palliation and local tumor control, without causing severe complications.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
VU University Medical Center, Amsterdam, Noord-Holland, Netherlands
Contact Details
Name: Martijn R Meijerink, MD, PhD
Affiliation: VU University Medical Center, Department of Radiology and Nuclear Medicine
Role: PRINCIPAL_INVESTIGATOR
Name: Geert Kazemier, Prof. Dr.
Affiliation: VU University Medical Center, Department of Surgery
Role: PRINCIPAL_INVESTIGATOR
Name: Cornelis van Kuijk, Prof. Dr.
Affiliation: VU University Medical Center, Head of Department of Radiology,
Role: STUDY_DIRECTOR
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