Lipiodol as an Imaging Biomarker of Tumor Necrosis After Transcatheter Chemoembolization Therapy in Patients With Primary and Metastatic Liver Cancer
The purpose of this study is to determine the whether Lipiodol can be used as an imaging biomarker, predicting tumor response to therapy in patients with primary and metastatic liver cancer. Lipiodol-based transarterial chemoembolization (TACE) has been an accepted standard of care procedure for unresectable liver lesions for several decades. Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s). Response to therapy will be evaluated every 1, 3 and 6 months by clinic visits, MRI/CT/PET scans and blood tests (to include assessment of liver function and tumor markers).
• 18 years of age or older.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
• Childs class of A or B (up to 9).
• Hepatocellular carcinoma (HCC) is unresectable with liver-predominant disease or subject has HCC and refused surgery or subject is diagnosed hepatic metastases from any solid tumor. (Multifocal HCC is acceptable, no diffuse HCC).
• Subject is voluntarily participating in the study and has signed the informed consent.