Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Aug 1, 2022

Keywords

ClinConnect Summary

The clinical trial titled "Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI" is exploring two different screening methods to detect liver cancer early in patients who have cirrhosis, a serious liver condition. The study aims to find out whether a shorter version of a specific type of MRI, combined with a blood test for liver cancer markers, is better at spotting cancer earlier than the usual ultrasound and blood test. Detecting liver cancer at earlier stages could lead to more effective treatments and potentially lower the risk of dying from the disease.

To participate in this trial, individuals must be between 18 and 75 years old and have cirrhosis confirmed by medical tests. They should also be at high risk for liver cancer, which may include having a current hepatitis C infection or specific scores indicating a higher chance of developing cancer. Participants will receive either the MRI or the ultrasound screening and will be monitored throughout the study. It’s important to note that people who have already been diagnosed with liver cancer or have certain medical conditions may not be eligible to join the trial.

Gender

ALL

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