Tissue Analysis After Tumor Ablation for Liver Metastases Leading to Immediate Retreatment
- Conditions
- Liver Metastases
- Registration Number
- NCT04143516
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria:<br><br> - Diagnosis of liver metastases from various primary tumors<br><br> - Confined liver disease or limited extrahepatic disease stable/controlled for at<br> least 4 months (extrahepatic disease amenable to treatment is allowed)<br><br> - Lesions of =3 cm in maximum diameter<br><br> - At least one FDG-avid lesion to be treated***<br><br> - INR < 1.5*<br><br> - Platelet count = 50,000<br><br>Exclusion Criteria:<br><br> - Age < 18<br><br> - Less than 5 mm distance to a structure (GI or biliary tract), that cannot be<br> protected from ablation injury with technical modifications such as hydro or air<br> dissection<br><br> - INR > 1.5 that cannot be corrected with fresh frozen plasma **<br><br> - Platelet count of <50,000 that cannot be corrected with transfusion<br><br> - More than 3 tumors in the liver<br><br> - More than 5 tumors of extrahepatic disease (including mediastinal nodes and<br> pulmonary nodules, abdominal or other lymph nodes, and bone metastasis)<br><br> - Presence of any peritoneal Carcinomatosis<br><br> - For patients on Coumadin, general clinical guidelines for IR ablation will be<br> followed.<br><br> - For patients with no FDG-PET avid tumors aim 2 of the protocol will not be<br> assessed
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tumor response
- Secondary Outcome Measures
Name Time Method