Irreversible Electroporation Ablation for Colorectal Metastases to the Lung

Not Applicable

Completed

• Conditions: Colorectal Metastases to the Lung
• Interventions: Device: Irreversible Electroporation Ablation

• Registration Number: NCT02461550
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The investigators are investigating the use of a new cancer treatment called Irreversible Electroporation (IRE). This treatment delivers electrical energy between two needles placed in a cancer. The electrical energy causes cells to die. While this has been used in patients for different applications, the investigators are trying to understand how safe and well it works in colon cancer that has spread to the lung. Once the irreversible electroporation procedure is completed during the operation, the surgeon will then remove the cancer according to standard procedure. As part of the study, they will be measuring safety of the electrical energy delivered and will be reviewing the resected specimen under the microscope.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-06-01
• Study First Submitted QC: 2015-06-01
• Study First Posted: 2015-06-03
• Status Verified: 2017-02
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Results First Submitted: 2017-10-26
• Results First Submitted QC: 2018-01-05
• Last Update Submitted: 2018-01-05
• Results First Posted: 2018-01-08
• Last Update Posted: 2018-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Diagnosed Colorectal cancer with oligometastatic colorectal cancer in the lung
• Lung lesion size is greater than 1 cm
• Patient will undergo surgical resection as per consultation with their thoracic surgeon and medical oncologist
• Patient is cleared to undergo paralytic anesthesia.
• Patients 18 years old and older

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Exclusion Criteria

• Patients with history of cardiac dysrhythmia
• Known heart failure (EF < 40%)
• Pacemaker/defibrillator
• Patient's with any metallic cardiac implant
• Patient on anti-coagulation therapy and are unable to stop therapy for the perioperative period
• Women who are pregnant and/or nursing

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IRE procedure	Irreversible Electroporation Ablation	The IRE procedure will be performed in the operating room at the time of scheduled clinical resection of colorectal lung metastases by the surgeon with guidance from the Interventional Radiologist.

Primary Outcome Measures

Name	Time	Method
The Frequency of Adverse Events	2 years	Safety will be measured by using the NCI Common Terminology Criteria for Adverse Events (CTCAE v4.0). The goal of this study is to establish safety.; If there are 3 or more grade 3 or higher device related AEs, then we will stop the study.

Trial Locations

Locations (4)

Memorial Sloan-Kettering at Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan-Kettering Cancer Center @ Suffolk; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering West Harrison; 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States