Comparing Ultrasound and MRI for Early Detection of Liver Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a randomized controlled trial aimed at comparing two screening methods for early detection of hepatocellular carcinoma (HCC) in patients with cirrhosis. Participants will be assigned to receive either abdominal ultrasound with serum alpha fetoprotein (AFP) or abbreviated magnetic resonance imaging (aMRI) with AFP, both conducted every six months. The study seeks to determine if aMRI can detect HCC at earlier stages compared to the standard ultrasound method, potentially leading to more effective treatments and reduced mortality rates. The trial will involve approximately 4,700 patients across 47 VA Medical Centers over three years.

Why it matters

Who can join: the full rules

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

Where it's running

• Birmingham VA Medical Center, Birmingham, AL
  Birmingham, Alabama, United States Recruiting
• Southern Arizona VA Health Care System, Tucson, AZ
  Tucson, Arizona, United States Recruiting
• Central Arkansas Veterans Healthcare System , Little Rock, AR
  Little Rock, Arkansas, United States Recruiting
• VA Long Beach Healthcare System, Long Beach, CA
  Long Beach, California, United States Recruiting
• VA Palo Alto Health Care System, Palo Alto, CA
  Palo Alto, California, United States Recruiting
• VA Northern California Health Care System, Mather, CA
  Sacramento, California, United States Recruiting

Study contacts

• Study coordinator: George N Ioannou, MD MS
• Email: George.Ioannou@va.gov
• Phone: (206) 277-3136

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.