NCT05486572 Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI
| NCT ID | NCT05486572 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Carcinoma, Hepatocellular |
| Study Type | INTERVENTIONAL |
| Enrollment | 4,700 participants |
| Start Date | 2023-11-03 |
| Primary Completion | 2030-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 4,700 participants in total. It began in 2023-11-03 with a primary completion date of 2030-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion 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 Exclusion Criteria: 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
Contact & Investigator
George N. Ioannou, MD MS
STUDY CHAIR
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Frequently Asked Questions
Who can join the NCT05486572 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Carcinoma, Hepatocellular. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05486572 currently recruiting?
Yes, NCT05486572 is actively recruiting participants. Contact the research team at George.Ioannou@va.gov for enrollment information.
Where is the NCT05486572 trial being conducted?
This trial is being conducted at Birmingham, United States, Tucson, United States, Little Rock, United States, Long Beach, United States and 11 additional locations.
Who is sponsoring the NCT05486572 clinical trial?
NCT05486572 is sponsored by VA Office of Research and Development. The principal investigator is George N. Ioannou, MD MS at VA Puget Sound Health Care System Seattle Division, Seattle, WA. The trial plans to enroll 4,700 participants.