This clinical trial studies the tumor samples from patients undergoing percutaneous ablation for cancer that has spread to the liver (liver metastases). Studying samples of the liver tumor before and after the ablation treatment may help doctors predict whether the percutaneous ablation worked.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01494324.
PRIMARY OBJECTIVE:
I. Establish that viable tumor (oxidative phosphorylation [OxPhos] antibody [AB], MitoTracker [MT] Red and Ki67 positive tumor cells) identified in tissue from the ablated tumor (adherent to the electrode and obtained with needle biopsy) is an independent predictor of local tumor progression (LTP) and ablation failure.
SECONDARY OBJECTIVES:
I. Calculate and correlate the volume of tumor perfusion and necrosis, using post-ablation dynamic liver computed tomography (CT), preferably including triphasic imaging, with the presence of viable tumor (OxPhos AB, MT Red, and Ki67 positive tumor cells) or coagulation necrosis of the tissue from the ablated tumor (adherent to the electrode and obtained with needle biopsy).
II. Correlate the presence of viable tumor (OxPhos AB, MT Red and Ki67 positive tumor cells) or coagulation necrosis of tissue from the ablated tumor (adherent to the electrode and obtained with needle biopsy) with peripheral blood levels of carcinoembryonic antigen (CEA). (Applies to patient with colon cancer liver metastases only)
III. Evaluate whether the presence of viable tumor (OxPhos AB, MT Red, and Ki67 positive tumor cells) identified in tissue from the ablated tumor (adherent to the electrode and obtained with needle biopsy) is a predictor of overall survival after percutaneous ablation of malignant colon cancer liver metastases (CLM). (Applies to patient with colon cancer liver metastases only)
OUTLINE:
Patients undergo biopsy before percutaneous ablation and an image-guided biopsy of the ablated liver tumor after percutaneous ablation.
After completion of study treatment, patients are followed up at 1-2 weeks, 4-8 weeks, and then every 2-4 months for 3 years.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorConstantinos Thasos Sofocleous