[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100373522":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":32,"centralContacts":36,"locations":44,"responsibleParty":62,"collaborators":22,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":22,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":22,"enrollmentInfo":73,"targetDuration":22,"studyType":76,"phases":77,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":46,"whyStopped":22,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Memorial Sloan Kettering Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with Liver Metastases","EXPERIMENTAL","The standard of care tumor ablation procedure, post-ablation biopsies and pre- and post-ablation PET scans. If the PET scan is positive (shows areas of cancer in the treated metastases), study participants will undergo additional needle biopsies of the positive areas on the scan. If the biopsies show areas of cancer cells that are still alive, the participants will be immediately retreated with a second ablation procedure.",[13,14,15],"Diagnostic Test: [18-F]- FDG - PET","Procedure: Tumor ablation (TA)","Diagnostic Test: PET\u002FCT Scan",[17,23,28],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DIAGNOSTIC_TEST","[18-F]- FDG - PET","Patients will undergo a limited non-contrast CT and first injection PET to localize the lesion",[9],null,{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":22},"PROCEDURE","Tumor ablation (TA)","Standard ablation with the intent to create a radius of ablation at least 10 mm larger than the largest lesion diameter in order to achieve a minimum of 5 mm ablation margin around the tumor. Any radiographically-identified and biopsy-confirmed residual tumor will be treated on site with immediate ablation. This repeat ablation is not standard of care but will be performed as described for the initial ablation (in the same procedure session) and follow up will be resumed.",[9],{"type":18,"name":29,"description":30,"armGroupLabels":31,"otherNames":22},"PET\u002FCT Scan","Eligible patients will undergo PET\u002FCT -guided tumor ablation as per standard IR guidelines. All patients will undergo PET\u002FCT again, within approximately 6 weeks (+\u002F- 2 weeks) of tumor ablation to evaluate for CN in the target tumor(s) or any sign of residual tissue enhancement, representing viable residual tumor and incomplete treatment.",[9],[33],{"name":34,"affiliation":5,"role":35},"Constantinos Sofocleous, MD, PhD","PRINCIPAL_INVESTIGATOR",[37,41],{"name":34,"role":38,"phone":39,"phoneExt":22,"email":40},"CONTACT","212-639-3379","sofoclec@mskcc.org",{"name":42,"role":38,"phone":43,"phoneExt":22,"email":22},"Efsevia Vakiani, MD,PhD","646-888-3060",[45],{"facility":5,"status":46,"city":47,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","New York","10065","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-74.00597,40.71427,{"lat":55,"lon":54},[58,59,60],{"name":34,"role":38,"phone":39,"phoneExt":22,"email":22},{"name":42,"role":38,"phone":43,"phoneExt":22,"email":22},{"name":61,"role":35,"phone":22,"phoneExt":22,"email":22},"Constantinos Sofocleous, MD,PhD",{"type":63,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100373522","phase-2-tissue-analysis-after-tumor-ablation-for-liver-metastases-leading-to-immediate-retreatment-100373522",false,"NCT04143516","Tissue Analysis After Tumor Ablation for Liver Metastases Leading to Immediate Retreatment","Clinical Trial Optimizing Tumor Ablation for Liver Metastases: Rapid Tissue Analysis Allowing for Immediate Retreatment; Metabolic Imaging Biomarker Validation; and Predictive Genetic Signatures","Inclusion Criteria:\n\n* Diagnosis of liver metastases from various primary tumors\n* Confined liver disease or limited extrahepatic disease stable\u002Fcontrolled for at least 4 months (extrahepatic disease amenable to treatment is allowed)\n* Lesions of ≤3 cm in maximum diameter\n* At least one FDG-avid lesion to be treated\\*\\*\\*\n* INR \\\u003C 1.5\\*\n* Platelet count ≥ 50,000\n\nExclusion Criteria:\n\n* Age \\\u003C 18\n* Less than 5 mm distance to a structure (GI or biliary tract), that cannot be protected from ablation injury with technical modifications such as hydro or air dissection\n* INR \\> 1.5 that cannot be corrected with fresh frozen plasma \\*\\*\n* Platelet count of \\\u003C50,000 that cannot be corrected with transfusion\n* More than 3 tumors in the liver\n* More than 5 tumors of extrahepatic disease (including mediastinal nodes and pulmonary nodules, abdominal or other lymph nodes, and bone metastasis)\n* Presence of any peritoneal Carcinomatosis\n\n  * For patients on Coumadin, general clinical guidelines for IR ablation will be followed.\n\n    * For patients with no FDG-PET avid tumors aim 2 of the protocol will not be assessed","ALL","18 Years",{"count":74,"type":75},200,"ESTIMATED","INTERVENTIONAL",[78,79],"PHASE2","PHASE3","This study will see whether collecting and analyzing needle biopsy samples from cancer liver metastases after a tumor ablation procedure will be able to identify cancer cells that are still alive. The results of these biopsies could help determine the next treatment for your cancer, but the biopsies could cause side effects.",[82],"Liver Metastases",[84,85,86,87,88],"Optimizing Tumor Ablation","Rapid Tissue Analysis","Metabolic Imaging Biomarker Validation","Predictive Genetic Signatures","19-332","2026-03-17",{"date":91,"type":92},"2026-03-19","ACTUAL",{"date":94,"type":92},"2019-10-25",{"date":96,"type":75},"2026-10",{"name":5,"class":6},1]