RECRUITING

Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-11-03
Study Completion:2031-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05486572

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Cirrhosis due to any underlying etiology diagnosed by one or more of the following:
  2. * Histology of liver biopsy
  3. * Radiologic criteria (nodular liver, evidence of portal hypertension)
  4. * Clinical signs of cirrhosis (gastroesophageal varices, ascites, hepatic encephalopathy)
  5. * 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
  6. 2. High Risk of Liver Cancer: This will be defined by one or more of the following:
  7. * Current HCV infection (detectable HCV RNA)
  8. * FIB-4 score 3.25, within 6 months of randomization
  9. * 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).
  10. 3. Age 18-75
  11. 4. Able to provide informed consent
  1. 1. Prior diagnosis or of HCC
  2. 2. Current suspicion of HCC
  3. 3. Prior receipt of organ transplantation
  4. 4. Currently listed for organ transplantation.
  5. 5. Participation in a conflicting HCC screening trial
  6. 6. Advanced liver dysfunction, defined by Child C Cirrhosis (CTP score 10), or MELD score \>20, within 6 months prior to randomization
  7. 7. Glomerular Filtration Rate (GFR) \<30 ml/min
  8. 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. 9. Estimated life expectancy \<5 years as determined by the clinical judgement of the Study Investigator
  10. 10. Contraindications to undergoing contrast-enhanced MRI:
  11. * Allergy to gadolinium-based contrast agents
  12. * MRI-incompatible implantable devices (e.g. pacemakers, defibrillators, resynchronization devices)
  13. * Implantable neurostimulation device
  14. * Implantable cochlear implant/ear implant
  15. * Drug infusion pumps (e.g. insulin pump, analgesic or chemotherapy pumps)
  16. * Metallic foreign bodies in or around the eye
  17. * Metallic fragments, such as bullets, shotgun pellets or shrapnel
  18. * Metallic body piercings that cannot be removed
  19. * Cerebral artery aneurysm clips
  20. * Severe claustrophobia
  21. * Unable to fit on MRI machine due to weight (weight \>400lbs) or body habitus
  22. 11. Inability to complete planned study visits (e.g. lives too far from VA, no transportation, etc.)
  23. 12. Currently pregnant

Contacts and Locations

Study Contact

George N Ioannou, MD MS
CONTACT
(206) 277-3136
George.Ioannou@va.gov

Principal Investigator

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

Study Locations (Sites)

VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, 90822
United States
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
United States
VA Northern California Health Care System, Mather, CA
Sacramento, California, 95655-4200
United States
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
United States
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003
United States
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211
United States
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770
United States
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612
United States
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
United States
James J. Peters VA Medical Center, Bronx, NY
Bronx, New York, 10468-3904
United States
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
United States
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104-4551
United States
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211
United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
United States
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705-2254
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-03
Study Completion Date2031-09-01

Study Record Updates

Study Start Date2023-11-03
Study Completion Date2031-09-01

Terms related to this study

Keywords Provided by Researchers

  • hepatic, oncology
  • liver
  • chronic diseases; health services and systems
  • prospective, randomized, clinical trial
  • magnetic resonance imaging; ultrasonography
  • cirrhosis; liver cancer

Additional Relevant MeSH Terms

  • Carcinoma, Hepatocellular
  • Cirrhosis