Examining Tumor Samples from Patients Undergoing Percutaneous Ablation of Liver Metastases

Inclusion Criteria

• Patients diagnosed with secondary hepatic malignancy
• Patients with confined liver disease or stable limited extrahepatic disease
• Lesions of 5 cm or less in maximum diameter
• Patients who are not surgical candidates or refuse to undergo surgery and choose any percutaneous ablation as an alternative treatment option
• International normalized ratio (INR) < 1.5 * For patients on Coumadin general clinical guidelines for interventional radiology (IR) ablation will be followed
• Platelet count >= 50,000

Exclusion Criteria

• Less than 5 mm distance of the tumor margin from a major vessel (> 7 mm in diameter) * This will not be considered an exclusion criteria when irreversible electroporation (IRE) or microwave is used
• 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
• Patient with more than 3 tumors treated with any percutaneous ablation
• Patients with more than 5 sites of extrahepatic disease (including nodes and pulmonary nodules)

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 Phase Phase NA

Trial Type Diagnostic

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Constantinos Thasos Sofocleous

• Primary ID 09-122
• Secondary IDs NCI-2016-00998
• Clinicaltrials.gov ID NCT01494324