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Comparing two imaging methods for early liver cancer detection in cirrhosis

Compares two screening scans for early liver cancer in adults with cirrhosis.

Key facts

Who runs it
VA Office of Research and Development
Where
Ann Arbor, Aurora, Baltimore, Birmingham, Boston, Charleston, Cleveland, Columbia, Dallas, Decatur, Durham, Houston, Little Rock, Long Beach, Louisville, Madison, Miami, New York, Omaha, Palo Alto, Philadelphia, Portland, Sacramento, Salisbury, Salt Lake City, San Diego, Seattle, St Louis, Tampa, The Bronx, Tucson, Washington D.C., West Haven, and West Los Angeles, United StatesSee the 34 sites
Trial code
Registry title
Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI
Status
Recruiting
People taking part
4,700 people, planned
Started
3 Nov 2023
Expected to end
1 Sept 2031
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Abbreviated Magnetic Resonance Imaging with serum AFP
  • Abdominal Ultrasound Screening with serum AFP
Record updated
17 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 75 with liver cirrhosis who are at high risk of liver cancer. It compares two screening scans for early cancer detection.

Age
18 to 75 years
Sex
All sexes can join.
Disease stage
Cirrhosis of the liver from any cause, at high risk of liver cancer. Advanced liver failure (Child C cirrhosis or MELD score >20) cannot join.
Earlier treatment
No earlier liver cancer diagnosis. No earlier organ transplant and not currently listed for one.
Biomarker or test result
High risk is shown by current HCV infection (detectable HCV RNA), a FIB-4 score of 3.25, or an estimated yearly liver cancer risk >2.5%.

Main reasons for not taking part

  • Earlier or suspected liver cancer
  • Organ transplant received or planned
  • Advanced liver failure (Child C or MELD score >20) or GFR <30 ml/min
  • Expected life span under 5 years
  • Cannot have a contrast MRI (for example pacemaker, metal fragments, severe claustrophobia), or currently pregnant

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • Glomerular Filtration Rate (GFR) <30 ml/min
  • Estimated life expectancy <5 years as determined by the clinical judgement of the Study Investigator
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in United States

  • VA Ann Arbor Healthcare System, Ann Arbor, MIAnn Arbor, United StatesContact: Grace L Su, MDTaking people
  • Rocky Mountain Regional VA Medical Center, Aurora, COAurora, United StatesContact: Ashley M Lane, MDTaking people
  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MDBaltimore, United StatesContact: Zurabi Lominadze, MDTaking people
  • Birmingham VA Medical Center, Birmingham, ALBirmingham, United StatesTaking people
  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MABoston, United StatesContact: Gyorgy Baffy, MDTaking people
  • Ralph H. Johnson VA Medical Center, Charleston, SCCharleston, United StatesContact: Don Rockey, MDTaking people
  • Louis Stokes VA Medical Center, Cleveland, OHCleveland, United StatesContact: Percia Davitkav, MDTaking people
  • Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SCColumbia, United StatesContact: Nicholas Hoppmann, MDTaking people
  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TXDallas, United StatesContact: Jacqueline Oleary, MDTaking people
  • Atlanta VA Medical and Rehab Center, Decatur, GADecatur, United StatesContact: Thuy-Van Hang, MDTaking people
  • Durham VA Medical Center, Durham, NCDurham, United StatesContact: Cynthia Moylan, MDTaking people
  • Michael E. DeBakey VA Medical Center, Houston, TXHouston, United StatesContact: Ruben Hernaez, MDTaking people
  • Central Arkansas Veterans Healthcare System, Little Rock, ARLittle Rock, United StatesContact: Ragesh Thandassery, MDTaking people
  • VA Long Beach Healthcare System, Long Beach, CALong Beach, United StatesContact: Morgan R Timothy, MDTaking people
  • Robley Rex VA Medical Center, Louisville, KYLouisville, United StatesContact: Ashutosh Barve, MDTaking people
  • William S. Middleton Memorial Veterans Hospital, Madison, WIMadison, United StatesContact: Adnan Said, MDTaking people
  • Miami VA Healthcare System, Miami, FLMiami, United StatesContact: Binu John, MDTaking people
  • VA NY Harbor Healthcare System, New York, NYNew York, United StatesContact: Daniel Dileo, MDTaking people
  • Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NEOmaha, United StatesContact: Peter Mannon, MDTaking people
  • VA Palo Alto Health Care System, Palo Alto, CAPalo Alto, United StatesContact: Cheung Ramsey, MDTaking people
  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PAPhiladelphia, United StatesContact: David Kaplan, MDTaking people
  • VA Portland Health Care System, Portland, ORPortland, United StatesContact: Janice Jou, MDTaking people
  • VA Northern California Health Care System, Mather, CASacramento, United StatesContact: Anthony Albanese, MDTaking people
  • Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NCSalisbury, United StatesContact: Leon Kundrotas, MDTaking people
  • VA Salt Lake City Health Care System, Salt Lake City, UTSalt Lake City, United StatesContact: Tuan Pham, MDTaking people
  • VA San Diego Healthcare System, San Diego, CASan Diego, United StatesContact: Heather Patton, MDTaking people
  • VA Puget Sound Health Care System Seattle Division, Seattle, WASeattle, United StatesContact: George N Ioannou, MD MSTaking people
  • St. Louis VA Medical Center John Cochran Division, St. Louis, MOSt Louis, United StatesContact: Melissa Kaltenbach, MDTaking people
  • James A. Haley Veterans' Hospital, Tampa, FLTampa, United StatesContact: George N Ioannou, MD MSNo longer taking part
  • James J. Peters VA Medical Center, Bronx, NYThe Bronx, United StatesContact: Tae H Lee, MDTaking people
  • Southern Arizona VA Health Care System, Tucson, AZTucson, United StatesContact: Bhupesh Pokhrel, MDTaking people
  • Washington DC VA Medical Center, Washington, DCWashington D.C., United StatesContact: Atoosa Rabiee, MDTaking people
  • VA Connecticut Healthcare System West Haven Campus, West Haven, CTWest Haven, United StatesContact: Sofia Jakab, MDTaking people
  • VA Greater Los Angeles Healthcare System, West Los Angeles, CAWest Los Angeles, United StatesContact: Joseph Pisegna, MDTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Abdominal Ultrasound Screening with serum AFPExisting treatment, for comparison

    abdominal ultrasound (US)+serum alpha fetoprotein (AFP) every 6 months from the time of recruitment until the end of year 8

  • Abbreviated Magnetic Resonance Imaging with serum AFPOther group

    Abdominal aMRI+ serum AFP every 6 months from the time of recruitment until the end of year 8

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
CSP #2023 - Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI (The PREMIUM Study)
Plain-language title
Comparing two imaging methods for early liver cancer detection in cirrhosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT05486572, who can take part
Publications
Record updated
17 June 2026