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Trial NCT05486572

Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI

Phase
Not given
Sponsor
VA Office of Research and Development
Conditions
Carcinoma, Hepatocellular; Cirrhosis
Ages
18–75 years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

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 18-75Age 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/minRenal 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 habitusBMI 11. Inability to complete planned study visits (e.g. lives too far from VA, no transportation, etc.) 12. Currently pregnantPregnancy

Restrictions found (4)

Recruiting in Massachusetts

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA · Boston, Suffolk County