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Trial record 60 of 72 for:    colon cancer AND Colorectal Neoplasms | ( Map: New Jersey, United States )

Irreversible Electroporation Ablation for Colorectal Metastases to the Lung

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02461550
Recruitment Status : Completed
First Posted : June 3, 2015
Results First Posted : January 8, 2018
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Colorectal Metastases to the Lung Device: Irreversible Electroporation Ablation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Irreversible Electroporation Ablation for Colorectal Metastases to the Lung
Actual Study Start Date : May 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

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



Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT02461550


Locations
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United States, New Jersey
Memorial Sloan-Kettering at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
United States, New York
Memorial Sloan-Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
Memorial Sloan Kettering West Harrison
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Stephen Solomon, MD Memorial Sloan Kettering Cancer Center
  Study Documents (Full-Text)

Documents provided by Memorial Sloan Kettering Cancer Center:

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02461550    
Other Study ID Numbers: 15-001
First Posted: June 3, 2015    Key Record Dates
Results First Posted: January 8, 2018
Last Update Posted: January 8, 2018
Last Verified: February 2017
Keywords provided by Memorial Sloan Kettering Cancer Center:
Irreversible Electroporation Ablation
15-001
Additional relevant MeSH terms:
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Neoplasm Metastasis
Lung Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases