Examinations of Tissue from Ablated Malignant Liver Metastases As Predictors of Outcome

Not Applicable

Active, not recruiting

Brief 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.

Recruitment & Eligibility

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*
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)
- for patients on Coumadin general clinical guidelines for IR ablation will be followed **This will not be considered an exclusion criteria when IRE or Microwave is used.
  - This will not be considered exclusion when IRE is used

Arm && Interventions

Group	Intervention	Description
CT guided percutaneous ablation	CT guided percutaneous ablation	The selected patients will undergo CT guided percutaneous ablation. The use of multi-tined electrode is encouraged, unless tumor location requires the use of an internally cooled needle electrode to eliminate injury to an adjacent vital structure or the operator prefers to use an internally cooled electrode for a specific reason.

Primary Outcome Measures

Name	Time	Method
Tumor response	3 years	will be measured according to EASL and RECIST. In the case of differences between these criteria, the EASL criteria will be used for clinical judgment and decisions.Tumor response will be determined at the discretion of the Principal Investigator in the case of overlapping ablation zones or lesions seen only in PET.

Secondary Outcome Measures

Name	Time	Method
Duration of treatment response	3 years	will be measured as the time from the date of first objective response until the first measurement of progression as determined by the central readers using the EASL criteria. Dynamic Liver CT scans, preferably including the liver triphasic examination will be conducted at each follow-up visit until progression.

Locations (1): Memorial Sloan Kettering Cancer Center
🇺🇸
New York, New York, United States

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