Irreversible Electroporation Ablation for Colorectal Metastases to the Lung

Colorectal Metastases to the Lung Clinical Trial

Official title:

Irreversible Electroporation Ablation for Colorectal Metastases to the Lung

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02461550
• Other study ID #: 15-001
• Status: Completed
• Phase: N/A
• First received: June 1, 2015
• Last updated: January 5, 2018
• Start date: May 2015
• Est. completion date: February 2017

Study information

• Verified date: February 2017
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Metastases to the Lung
• Lung Neoplasms
• Neoplasm Metastasis

Intervention

Device:
• Irreversible Electroporation Ablation

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years

External Links

•   Memorial Sloan Kettering Cancer Center