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Tissue Analysis for Immediate Re-treatment after Tumor Ablation for Liver Metastases
Trial Status: active
This phase II/III trial studies tissue analysis for immediate re-treatment after tumor ablation for cancer that has spread to the liver (liver metastases). Tumor ablation involves the destruction of tissue using a technique such as heat or electrical current. Examining tissue samples from treated metastases right after ablation may show whether any cancer cells are still alive. This may help doctors immediately re-treat affected areas with a second round of thermal ablation and control the growth and spread of the disease.
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
* For patients with no FDG-PET avid tumors aim 2 of the protocol will not be assessed
International normalized ratio (INR) < 1.5
Platelet count >= 50,000
Exclusion Criteria
Age < 18
Less than 5 mm distance to a structure (gastrointestinal [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
* For patients on Coumadin, general clinical guidelines for IR ablation will be followed
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04143516.
I. Validate imprint cytology (IC) and mitotracker (MT) fluorescent stain as an accurate histologic assessment of ablated liver tumors that can distinguish between coagulation necrosis/thermal artifacts and residual malignant cells surviving within the ablation zone (AZ), able to proliferate and lead to subsequent local tumor progression (LTP).
II. Evaluate whether immediate re-ablation for those with visible viable tumor, based on cytopathologic and fluorescence assessments improve clinical outcomes.
SECONDARY OBJECTIVES:
I. Validate the use of fludeoxyglucose F 18 (18F-FDG) positron emission tomography (PET) as an immediate surrogate imaging biomarker of complete tumor ablation (TA).
II. Identify genetic factors associated with sensitivity/resistance to TA and to identify patients who benefit the most from TA.
OUTLINE:
Patients receive fludeoxyglucose F 18 via injection and undergo PET scan and biopsy. Patients then undergo standard of care tumor ablation. After completion of thermal ablation, patients receive additional fludeoxyglucose F 18 injection and undergo second PET scan and biopsy. If second PET scan is positive, patients undergo additional biopsy to positive areas. If biopsy samples are positive, patients are re-treated with tumor ablation. Patients undergo computed tomography (CT) scan, PET scan and blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 6 weeks, every 3 months for 3 years, and then annually thereafter.
Trial PhasePhase II/III
Trial Typediagnostic
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorConstantinos Thasos Sofocleous
