Irreversible Electroporation Ablation for Colorectal Metastases to the Lung

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Colorectal Metastases to the Lung

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IRE procedure

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.

Group Type EXPERIMENTAL

Irreversible Electroporation Ablation

Intervention Type DEVICE

Interventions

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Irreversible Electroporation Ablation

Intervention Type DEVICE

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No