Dynamic Contrast-enhanced Magnetic Resonance Imaging in Evaluation of Liver Functional Status and Treatment Efficacy in Patients With Hepatocellular Carcinoma After Locoregional Therapy
6.1.1. HCC diagnosed according to the AASLD guideline1: tumor size > 1cm in a cirrhotic
liver with typical appearance in one dynamic imaging study (hypervascular in the arterial
phase with washout in the portal venous or delayed phase), or the tumor is biopsied.
6.1.2. Patients who had undergone surgery for the treatment of HCC are allowed. 6.1.3. At
least one measurable tumor, according to RECIST version 1.1. 6.1.4. Age 18 years. 6.1.5.
Chronic hepatitis B. 6.1.6. ECOG performance status 0 or 1. 6.1.7. Life expectancy 2
months. 6.1.8. Child-Pugh class A or B liver function with a Child-Pugh score of ≦ 8.
6.1.9. Liver transaminases (ALT and AST) 300 IU/L; total bilirubin 2 mg/dL; serum
creatinine 2 mg/dL.
6.1.10.Specific criteria for the TACE cohort: tumors distributed within one lobe and with
maximal diameter of 10cm (for adequate amount of non-tumorous liver parenchyma for
6.1.11.Specific criteria for the RFA cohort: single tumor with size of less than 5cm in
diameter or tumors 3 or less in number with size of less than 3cm in diameter. The target
tumor(s) can be approached by ultrasound guidance.
6.2.1. Chronic hepatitis C. 6.2.2. Diffuse or infiltrative pattern of disease. 6.2.3.
Previous TACE procedure for treatment of HCC. 6.2.4. Hepatic artery, hepatic vein, or
portal venous thrombosis. 6.2.5. History of HCC tumor rupture. 6.2.6. Presence of
extra-hepatic metastases. 6.2.7. Documentation of large intrahepatic or portal-caval
shunts. 6.2.8. Contraindication for DCE-MRI, including known contrast allergy,
electronically operated implants or devices, and claustrophobia.
6.2.9. Unable to cooperate well with breath holding comments during MRI examination or RFA
6.2.10.Major systemic diseases that the investigator considers inappropriate for
6.2.11.Other severe acute or chronic medical or psychiatric condition, or laboratory
abnormality that may increase the risk associated with study participation and in the
judgment of the investigator would make the patient inappropriate for entry into this
6.2.12.Coagulation abnormality, including platelet count < 50000/L, prolongation of
prothrombin time 5 seconds or INR >1.5) which could not be corrected by component therapy.
6.2.13.Obvious ascites which possibly cause bleeding complication. 6.2.14.History or
clinically significant cardiac arrhythmia that is considered risky for invasive procedures
including TACE or RFA.
6.2.15.Woman who are pregnant or lactating.