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NCT04143516PHASE2, PHASE3Recruiting

Tissue Analysis After Tumor Ablation for Liver Metastases Leading to Immediate Retreatment

Memorial Sloan Kettering Cancer Center

Start Date

10/25/2019

Completion Date

10/1/2026

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Diagnosis of liver metastases from various primary tumors * Confined liver disease or limited extrahepatic disease stable/controlled for at least 4 months (extrahepatic disease amenable to treatment is allowed) * Lesions of ≤3 cm in maximum diameter * At least one FDG-avid lesion to be treated\*\*\* * INR \< 1.5\* * Platelet count ≥ 50,000 Exclusion Criteria: * Age \< 18 * 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 * INR \> 1.5 that cannot be corrected with fresh frozen plasma \*\* * Platelet count of \<50,000 that cannot be corrected with transfusion * More than 3 tumors in the liver * More than 5 tumors of extrahepatic disease (including mediastinal nodes and pulmonary nodules, abdominal or other lymph nodes, and bone metastasis) * Presence of any peritoneal Carcinomatosis * For patients on Coumadin, general clinical guidelines for IR ablation will be followed. * For patients with no FDG-PET avid tumors aim 2 of the protocol will not be assessed

Interventions

DIAGNOSTIC_TEST

[18-F]- FDG - PET

PROCEDURE

Tumor ablation (TA)

DIAGNOSTIC_TEST

PET/CT Scan

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Conditions

Liver Metastases

Locations

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States