Irreversible Electroporation Ablation for Colorectal Metastases to the Lung

January 5, 2018 updated by: Memorial Sloan Kettering Cancer Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan-Kettering at Basking Ridge
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan-Kettering Cancer Center @ Suffolk
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering West Harrison
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Irreversible Electroporation Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Frequency of Adverse Events
Time Frame: 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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Stephen Solomon, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

June 1, 2015

First Submitted That Met QC Criteria

June 1, 2015

First Posted (Estimate)

June 3, 2015

Study Record Updates

Last Update Posted (Actual)

January 8, 2018

Last Update Submitted That Met QC Criteria

January 5, 2018

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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