Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI

Prior treatment

• Prior diagnosis or of HCC
• Prior receipt of organ transplantation
• Currently listed for organ transplantation.
• Advanced liver dysfunction, defined by Child C Cirrhosis (CTP score 10), or MELD score \>20, within 6 months prior to randomization

Other illness

• Multiple comorbid conditions resulting in limited life expectancy, defined by a cirrhosis-specific comorbidity index (CirCom)112 score 3. Of note, early stage malignancies of the bladder, lung, or prostate will not be excluded.
• Contraindications to undergoing contrast-enhanced MRI:
  • Allergy to gadolinium-based contrast agents
  • MRI-incompatible implantable devices (e.g. pacemakers, defibrillators, resynchronization devices)
  • Implantable neurostimulation device
  • Implantable cochlear implant/ear implant
  • Drug infusion pumps (e.g. insulin pump, analgesic or chemotherapy pumps)
  • Metallic foreign bodies in or around the eye
  • Metallic fragments, such as bullets, shotgun pellets or shrapnel
  • Metallic body piercings that cannot be removed
  • Cerebral artery aneurysm clips
  • Severe claustrophobia
  • Unable to fit on MRI machine due to weight (weight \>400lbs) or body habitus

Lab values

• Glomerular Filtration Rate (GFR) \<30 ml/min

Age

• Estimated life expectancy \<5 years as determined by the clinical judgement of the Study Investigator

Other

• Current suspicion of HCC
• Participation in a conflicting HCC screening trial
• Inability to complete planned study visits (e.g. lives too far from VA, no transportation, etc.)
• Currently pregnant

• Cirrhosis due to any underlying etiology diagnosed by one or more of the following:
  • Histology of liver biopsy
  • Radiologic criteria (nodular liver, evidence of portal hypertension)
  • Clinical signs of cirrhosis (gastroesophageal varices, ascites, hepatic encephalopathy)
  • Vibration controlled transient elastography (VCTE, specifically Fibroscan, which is available in all participating sites) with liver stiffness \>12.5kPa or magnetic resonance elastography \>5.0 kPa
• High Risk of Liver Cancer: This will be defined by one or more of the following:
  • Current HCV infection (detectable HCV RNA)
  • FIB-4 score 3.25, within 6 months of randomization
  • Estimated annual HCC incidence \>2.5%, within 6 months of randomization, calculated by VA-specific models that the investigators developed (available on the national VA ALD Dashboard and at www.hccrisk.com).
• Age 18-75
• Able to provide informed consent