Health TrialsbyHealthPanel

Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI

ConditionsCarcinoma, HepatocellularCirrhosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorVA Office of Research and Development

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Prior diagnosis or of HCC

Current suspicion of HCC

Prior receipt of organ transplantation

Currently listed for organ transplantation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Abbreviated Magnetic Resonance Imaging with serum AFP

    Other intervention

    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 intervention

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

Treatment groups

4,700 Participants
are divided into 2 treatment groups
Group A: Abdominal Ultrasound Screening with serum AFPActive comparator 1 intervention
Group B: Abbreviated Magnetic Resonance Imaging with serum AFPOther 1 intervention

Trial outcomes

Primary outcomes

1

Hepatocellular Carcinoma Mortality

death due to liver cancer

Time frame
8 years

Secondary outcomes

1

Stage of Hepatocellular Carcinoma at diagnosis

Stage of Hepatocellular Carcinoma at time of diagnosis

Time frame
8 years
2

Receipt of potentially curative treatments for Hepatocellular Carcinoma

Receipt of potentially curative treatments for Hepatocellular Carcinoma

Time frame
8 years
3

Overall Survival

overall survival of liver cancer

Time frame
8 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Source ClinicalTrials.gov
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