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Irreversible Electroporation Ablation for Colorectal Metastases to the Lung

Primary Purpose

Colorectal Metastases to the Lung

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Irreversible Electroporation Ablation
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Metastases to the Lung focused on measuring Irreversible Electroporation Ablation, 15-001

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering at Basking Ridge
  • Memorial Sloan-Kettering Cancer Center @ Suffolk
  • Memorial Sloan Kettering West Harrison
  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IRE procedure

Arm Description

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.

Outcomes

Primary Outcome Measures

The Frequency of Adverse Events
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.

Secondary Outcome Measures

Full Information

First Posted
June 1, 2015
Last Updated
January 5, 2018
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02461550
Brief Title
Irreversible Electroporation Ablation for Colorectal Metastases to the Lung
Official Title
Irreversible Electroporation Ablation for Colorectal Metastases to the Lung
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Metastases to the Lung
Keywords
Irreversible Electroporation Ablation, 15-001

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IRE procedure
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Irreversible Electroporation Ablation
Primary Outcome Measure Information:
Title
The Frequency of Adverse Events
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Solomon, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering at Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center @ Suffolk
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering West Harrison
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

Irreversible Electroporation Ablation for Colorectal Metastases to the Lung

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