Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI

Conditions

• Carcinoma, Hepatocellular
• Cirrhosis

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Abbreviated Magnetic Resonance Imaging with serum AFP — OTHER
  Abdominal aMRI+ serum AFP every 6 months from the time of recruitment until the end of year 8
• Abdominal Ultrasound Screening with serum AFP — OTHER
  abdominal ultrasound (US)+serum alpha fetoprotein (AFP) every 6 months from the time of recruitment until the end of year 8

Study Details

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.

Key Dates

Start date

Nov 3, 2023

Status verified

Apr 2026

Primary completion

Sep 1, 2030

Completion

Sep 1, 2031

Study Design

Enrollment

4,700 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Active Comparator: Abdominal Ultrasound Screening with serum AFP
  abdominal ultrasound (US)+serum alpha fetoprotein (AFP) every 6 months from the time of recruitment until the end of year 8
• Other: Abbreviated Magnetic Resonance Imaging with serum AFP
  Abdominal aMRI+ serum AFP every 6 months from the time of recruitment until the end of year 8

Primary Outcome Measure

Hepatocellular Carcinoma Mortality [ Time Frame: 8 years ]

Central Contacts

• George N Ioannou, MD MS
  (206) 277-3136
  [email protected]

Locations (32)

Find similar trials in Birmingham, AL

Related Studies

• Safety and Efficacy of Everolimus Treatment in Liver Transplantation for Liver Cancer
  PHASE4 · Enrolling By Invitation · Baylor Research Institute · San Francisco, California
• Blood Collection Biorepository for Liver Disease Research
  Recruiting · State University of New York at Buffalo · Buffalo, New York
• Mechanisms of Malnutrition in Cirrhosis With Portosystemic Shunting
  Recruiting · The Cleveland Clinic · Cleveland, Ohio
• Novel Tracer Methods to Evaluate Muscle Protein Metabolism in Cirrhosis
  Recruiting · The Cleveland Clinic · Cleveland, Ohio