Colorectal Metastases to the Lung
Conditions
Keywords
Irreversible Electroporation Ablation, 15-001
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.
Interventions
DEVICEIrreversible Electroporation Ablation
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Frequency of Adverse Events | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Irreversible Electroporation Ablation | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | IRE Procedure |
|---|---|
| Age, Continuous | 42 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 2 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 2 |
| other Total, other adverse events | 2 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
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.
Time frame: 2 years
Population: Data were not collected