Examinations of Tissue From Ablated Malignant Liver Metastases as Predictors of Outcome
Conditions
Liver Cancer
Conditions: Keywords
Liver, Thermal Ablation, Dynamic CT, 09-122
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: CT guided percutaneous ablation
Type: Other
Overall Status
Recruiting
Summary
The purpose of this study is to see if the investigators can do some tests on tissue from the area of the ablation. The investigators want to know if a test can help predict whether the ablation worked.

The treated tumor is normally evaluated with CT. The CT shows signs of treated tumor(s) in the area treated by ablation. However, cancer cells may begin to grow in or near the treated area. The CT scan cannot tell us if the cells are new cancer cells or if they are healthy liver cells that just look different because of the ablation. The test the investigators will study should be able to tell us the difference.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patients with diagnosed with secondary hepatic malignancy;

- Patients with confined liver disease or stable limited extrahepatic disease;

- Lesions of 5cm or less in maximum diameter;

- Patients who are not surgical candidates or refuse to undergo surgery and choose any percutaneous ablation as an alternative treatment option.

- INR<1.5 *for patients on Coumadin general clinical guidelines for IR ablation will be followed.

- Platelet count > or = to 50,000

Exclusion Criteria:

- Patients < 18

- Less than 5 mm distance of the tumor margin from a major vessel >7mm in diameter)

- Less than 5 mm distance to a structure (GI or biliary tract), that cannot be protected from

- the ablation injury with technical modifications such as hydro or air dissection.

- INR > 1.5 that cannot be corrected with fresh frozen Plasma *for patients on Coumadin general clinical guidelines for IR ablation will be followed.

- Platelet count of <50,000 that cannot be corrected with transfusion.

- Patient with more than 3 tumors treated with any percutaneous ablation

- Patients with more than 5 sites of extrahepatic disease (including nodes and pulmonary nodules)
Location
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Constantinos Sofocleous, MD - 212-639-3379
Start Date
October 2009
Completion Date
October 2015
Sponsors
Memorial Sloan Kettering Cancer Center
Source
Memorial Sloan Kettering Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page