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New treatment option for Carcinoma, Hepatocellular
Official title Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI
ClinicalTrials.gov ID: NCT05486572
What this study is testing
- What it's testing
- 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.
- Time commitment: about 3 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
You likely can't join if
- Prior diagnosis or of HCC
- Current suspicion of HCC
- Prior receipt of organ transplantation
- Currently listed for organ transplantation.
- Participation in a conflicting HCC screening trial
- Advanced liver dysfunction, defined by Child C Cirrhosis (CTP score 10), or MELD score \>20, within 6 months prior to randomization
See the full eligibility criteria
- 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
- 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).
- Age 18-75
- Able to provide informed consent
- Prior diagnosis or of HCC
- Current suspicion of HCC
- Prior receipt of organ transplantation
- Currently listed for organ transplantation.
- Participation in a conflicting HCC screening trial
- Advanced liver dysfunction, defined by Child C Cirrhosis (CTP score 10), or MELD score \>20, within 6 months prior to randomization
- Glomerular Filtration Rate (GFR) \<30 ml/min
- 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...
- Estimated life expectancy \<5 years as determined by the clinical judgement of the Study Investigator
- 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
- Inability to complete planned study visits (e.g. lives too far from VA, no transportation, etc.)
- Currently pregnant
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Long Beach, California, United States
- Palo Alto, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- West Los Angeles, California, United States
- Aurora, Colorado, United States
- West Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Decatur, Georgia, United States
- Louisville, Kentucky, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
+ 14 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Long Beach, California, United States; Palo Alto, California, United States; Sacramento, California, United States and 28 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.