Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI

Summary

The study is a randomized trial of two different screening methods for early detection of liver cancer in patients with cirrhosis of the liver. The goal of PREMIUM is to compare an abbreviated version of the diagnostic gold standard for HCC (aMRI) +AFP to the standard-of-care screening (US+AFP) in patients at high risk of developing HCC. The investigators hypothesize that HCC will be detected at earlier stages, allowing for more curative treatments and resulting in a reduction in HCC-related mortality.

Eligibility

Inclusion Criteria:

1. 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
2. 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).
3. Age 18-75
4. Able to provide informed consent

Exclusion Criteria:

1. Prior diagnosis or of HCC
2. Current suspicion of HCC
3. Prior receipt of organ transplantation
4. Currently listed for organ transplantation.
5. Participation in a conflicting HCC screening trial
6. Advanced liver dysfunction, defined by Child C Cirrhosis (CTP score 10), or MELD score \>20, within 6 months prior to randomization
7. Glomerular Filtration Rate (GFR) \<30 ml/min
8. 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.
9. Estimated life expectancy \<5 years as determined by the clinical judgement of the Study Investigator
10. 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
11. Inability to complete planned study visits (e.g. lives too far from VA, no transportation, etc.)
12. Currently pregnant

Conditions5

Locations17 sites

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