N/A
Completed N=2
Irreversible Electroporation Ablation for Colorectal Metastases to the Lung
Colorectal Metastases to the Lung
Source: ClinicalTrials.gov NCT02461550 ↗
Enrolled (actual)
2
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcomePrimary: The Frequency of Adverse Events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Frequency of Adverse Events |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT02461550). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.