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PANFIRE Study: Irreversible Electroporation (IRE) to Treat Locally Advanced Pancreatic Carcinoma (PANFIRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01939665
Recruitment Status : Completed
First Posted : September 11, 2013
Last Update Posted : December 20, 2022
Sponsor:
Information provided by (Responsible Party):
Dr. M.R. Meijerink, Amsterdam UMC, location VUmc

Study Description
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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.


Condition or disease Intervention/treatment Phase
Locally Advanced Pancreatic Carcinoma (LAPC) Non-metastasized Unresectable Pancreatic Carcinoma Pancreatic Cancer Device: NanoKnife "Irreversible electroporation (IRE)" Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PANFIRE - Pilot-study: Non-thermal Ablation Using Irreversible Electroporation (IRE) to Treat Locally Advanced Pancreatic Carcinoma - a Phase I Clinical Trial
Actual Study Start Date : September 2013
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Irreversible electroporation
Single arm study: Percutaneous irreversible electroporation of locally advanced pancreatic carcinoma
 Device: NanoKnife "Irreversible electroporation (IRE)"
Tumor ablation with irreversible electroporation with the NanoKnife
Other Names:
  • IRE
  • NanoKnife


Outcome Measures
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Primary Outcome Measures :
  1. Safety (number of adverse events) [ Time Frame: early: 90 days; late: 12 months ]
    Number of adverse events of IRE-treatment (within 12 months after treatment) are registered and analyzed according to the CTCAE version 4.0. Complications related to IRE are early complications during hospital admission (e.g. bile leak, bowel leak, infection, pancreatitis), or late complications of IRE such as bile duct stenosis that become apparent during follow-up in the year after treatment.


Secondary Outcome Measures :
  1. Tumor response [ Time Frame: 12 months ]
    • Ablation success: the ability to deliver the planned therapy and at 3 months to have no evidence of residual tumor;
    • Local recurrence rate (LRR): defined as the reappearance of viable tumor after a period of time during which viable tumor could not be detected;
    • Overall survival and (local and distant) progression-free survival.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Screening must be performed no longer than 2 weeks prior to study inclusion.

  • Radiologic confirmation of LAPC by at least ceCT of chest and abdomen (with the upper abdomen scanned according to a dedicated 3mm slice multiphase pancreatic tumor protocol), performed maximum 2 weeks prior to the procedure;
  • Maximum tumor diameter ≤ 5 cm;
  • Histological or cytological confirmation of pancreatic adenocarcinoma;
  • Age ≥ 18 years;
  • ASA-classification 0 - 3
  • Life expectancy of at least 12 weeks;

  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to definite inclusion;

    • Hemoglobin ≥ 5.6 mmol/L;
    • Absolute neutrophil count (ANC) ≥ 1,500/mm3;
    • Platelet count ≥ 100*109/l;
    • Total bilirubin ≤ 1.5 times the upper limit of normal (ULN);
    • ALT and AST ≤ 2.5 x ULN;
    • Serum creatinine ≤ 1.5 x ULN or a calculated creatinine clearance ≥ 50 ml/min;
    • Prothrombin time or INR < 1.5 x ULN;
    • Activated partial thromboplastin time < 1.25 x ULN (therapeutic anticoagulation therapy is allowed if this treatment can be interrupted as judged by the treating physician);
  • Written informed consent;

Exclusion Criteria:

  • Resectable pancreatic adenocarcinoma as discussed by our multidisciplinary hepatobiliary team;
  • Extrapancreatic metastases;
  • Successful down staging after (radio)chemotherapy from previous unresectable/borderline tumor to resectable tumor;
  • Stage IV pancreatic carcinoma;
  • History of epilepsy;

  • History of cardiac disease:

    • Congestive heart failure >NYHA class 2;
    • Active Coronary Artery Disease (defined as myocardial infarction within 6 months prior to screening);
    • Cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers for antihypertensive regimen are permitted);
  • Uncontrolled hypertension. Blood pressure must be ≤160/95 mmHg at the time of screening on a stable antihypertensive regimen;
  • Compromised liver function (e.g. signs of portal hypertension, INR > 1,5 without use of anticoagulants, ascites);
  • Uncontrolled infections (> grade 2 NCI-CTC version 3.0);
  • Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment;
  • Immunotherapy ≤ 6 weeks prior to the procedure;
  • Chemotherapy ≤ 6 weeks prior to the procedure;
  • Radiotherapy ≤ 6 weeks prior to the procedure;
  • Concomitant use of anti-convulsive and anti-arrhythmic drugs (other than beta blockers used for antihypertensive);
  • Allergy to contrast media;
  • Any implanted stimulation device;
  • Any implanted metal stent/device within the area of ablation that cannot be removed;
  • Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study;

Of note, patients with contra-indications for MRI will not be excluded from participation: in this case radiologic follow-up will consist of CT-scanning according to protocol.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939665


Locations
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Netherlands
VU University Medical Center
Amsterdam, Noord-Holland, Netherlands, 1081 HV
Sponsors and Collaborators
Amsterdam UMC, location VUmc
Investigators
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Principal Investigator: Martijn R Meijerink, MD, PhD VU University Medical Center, Department of Radiology and Nuclear Medicine
Principal Investigator: Geert Kazemier, Prof. Dr. VU University Medical Center, Department of Surgery
Study Director: Cornelis van Kuijk, Prof. Dr. VU University Medical Center, Head of Department of Radiology,
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. M.R. Meijerink, Dr., Amsterdam UMC, location VUmc
ClinicalTrials.gov Identifier: NCT01939665    
Other Study ID Numbers: NL42888.029.13
2013/155 ( Registry Identifier: 2013/155 )
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: December 20, 2022
Last Verified: December 2022
Keywords provided by Dr. M.R. Meijerink, Amsterdam UMC, location VUmc:
Locally advanced pancreatic carcinoma
LAPC
Irreversible electroporation
NanoKnife
IRE
 Safety
Efficacy
Non-thermal ablation
Percutaneous ablation
Low Energy Direct Current
Additional relevant MeSH terms:
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Carcinoma
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases