Completed
NCT Number: NCT02461550
Irreversible Electroporation Ablation for Colorectal Metastases to the Lung
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Memorial Sloan-Kettering at Basking Ridge, Basking Ridge, New Jersey, United States
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Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
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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.
Sponsors and collaborators
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Registry information
Important dates
- Study start
- 2015
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Jun 3, 2015
- Registry last updated
- Jan 8, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.