A Study of the Use of Irreversible Electroporation in Pancreatic Ductal Cancer
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|ClinicalTrials.gov Identifier: NCT03257150|
Recruitment Status : Recruiting
First Posted : August 22, 2017
Last Update Posted : February 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Ductal Adenocarcinoma||Procedure: Irreversible Electroporation Device: NanoKnife System Drug: 18F-Fluoroazomycin arabinoside||Not Applicable|
In this phase 1/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 of the study will have a biopsy at the time of laparotomy. A baseline positron emission tomography (PET) scan using a contrast called [F-18]-Fluoroazomycin Arabinoside (FAZA) will be performed post enrolment and pre-study treatment to evaluate the levels of hypoxia in the tumour. A further scan will be performed at the first follow-up 12 weeks post completion of treatment. Blood will be collected of 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 and 24 weeks follow up. Quality of Life (QOL) questionnaires will be completed at baseline and during the study. Patients will be given optional consent for biobanking of left over tissue and blood for future analysis. Patients will be followed up 4 weeks post treatment, then every 12 weeks until death.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Irreversible Electroporation for Locally Advanced Pancreatic Ductal Adenocarcinoma (LEAP TRIAL): A Phase I/II Prospective Trial|
|Actual Study Start Date :||September 22, 2017|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||September 1, 2021|
Experimental: Study Treatment
For the patients with locally advanced pancreatic ductal adenocarcinoma:
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.
Device: NanoKnife System
A system consisting of electrode probes connected to a machine. The probes will be surgically placed around the cancer tumor.
Drug: 18F-Fluoroazomycin arabinoside
Positron Emission Tomography (PET) imaging agent for assessment of tumor hypoxia.
Other Name: 18F-FAZA
- Adverse event rate [ Time Frame: 30 days post IRE or index hospitalization ]
- Overall survival rate [ Time Frame: Date of IRE treatment to the date of death, up to 2 years ]
- Progression-free survival rate [ Time Frame: IRE treatment to the date of documented disease progression or death, up to 2 years ]
- Overall survival rate of disease [ Time Frame: Date of disease diagnosis to date of death, up to 2 years ]
- Progression-free survival rate of disease [ Time Frame: Date of disease diagnosis to date of death, up to 2 years ]
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): NCT03257150
|Contact: Anna Dodd||416-946-4501 ext email@example.com|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Anna Dodd 416-946-4501 ext 3176 firstname.lastname@example.org|
|Principal Investigator: Alice C Wei, MD|
|Principal Investigator:||Alice C Wei, MD||Princess Margaret Cancer Centre|