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
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)
- AgeOutrightinclusion
age <= 75
Show in the text - BMIOutrightexclusion
weight > 400 lbs
Show in the text - PregnancyOutrightexclusionShow in the text
- RenalConditionalexclusion
GFR < 30 ml/min
Show in the text
Recruiting in Massachusetts
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA · Boston, Suffolk County