Status:
ACTIVE_NOT_RECRUITING
Examinations of Tissue From Ablated Malignant Liver Metastases as Predictors of Outcome
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Rockefeller University
Conditions:
Liver Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 worke...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 27 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01494324
Start Date
October 27 2009
End Date
October 1 2026
Last Update
January 2 2026
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065