Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI

Description

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.

Conditions

Carcinoma, Hepatocellular, Cirrhosis

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Study Overview

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Study Details

Study overview

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.

CSP #2023 - Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI (The PREMIUM Study)

Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI

Condition
Carcinoma, Hepatocellular
Intervention / Treatment

-

Contacts and Locations

Long Beach

VA Long Beach Healthcare System, Long Beach, CA, Long Beach, California, United States, 90822

Palo Alto

VA Palo Alto Health Care System, Palo Alto, CA, Palo Alto, California, United States, 94304-1207

Sacramento

VA Northern California Health Care System, Mather, CA, Sacramento, California, United States, 95655-4200

San Diego

VA San Diego Healthcare System, San Diego, CA, San Diego, California, United States, 92161-0002

West Los Angeles

VA Greater Los Angeles Healthcare System, West Los Angeles, CA, West Los Angeles, California, United States, 90073-1003

Aurora

Rocky Mountain Regional VA Medical Center, Aurora, CO, Aurora, Colorado, United States, 80045-7211

West Haven

VA Connecticut Healthcare System West Haven Campus, West Haven, CT, West Haven, Connecticut, United States, 06516-2770

Tampa

James A. Haley Veterans' Hospital, Tampa, FL, Tampa, Florida, United States, 33612

Boston

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA, Boston, Massachusetts, United States, 02130-4817

Ann Arbor

VA Ann Arbor Healthcare System, Ann Arbor, MI, Ann Arbor, Michigan, United States, 48105-2303

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

VA Office of Research and Development,

George N. Ioannou, MD MS, STUDY_CHAIR, VA Puget Sound Health Care System Seattle Division, Seattle, WA

Study Record Dates

2031-09-01