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Abbreviated MRI for Liver Cancer Screening in Cirrhotic Patients, the FAST-MRI Study
Trial Status: active
This study compares the diagnostic value of an abbreviated magnetic resonance imaging (MRI) protocol compared to ultrasound (or sonography) for screening of liver cancer. MRI uses magnetic waves to look at soft tissues in the body. Ultrasound uses high-frequency sound waves to produce precise images of soft tissues within the body. Information gained from this trial may help to determine whether abbreviated MRI is superior to ultrasound for diagnosis of liver cancer.
Inclusion Criteria
Liver cirrhosis of any etiology (diagnosed clinically and/or on blood tests and/or on Fibroscan and/or histologically and/or on cross-sectional imaging)
It is permissible to include patients without prior negative imaging available as long as there is a clinical indication for HCC screening
Both genders
Age > 18 years
Enrolled in screening/surveillance program for HCC
Clinically indicated imaging-based screening for HCC
Willing and able to complete all study procedures within specified time windows
Ability to understand and the willingness to sign a written informed consent or similar
Enrollment to other concurrent studies is permissible
Exclusion Criteria
MRI contra-indications will follow local standard of care site policies used for clinical liver MRIs. At Icahn School of Medicine at Mount Sinai (ISMMS), these include metal implants, suspected or confirmed metal in eyes, cardiac pacemaker, implanted defibrillator, other implanted electronic devices, pregnancy, severe claustrophobia, acute kidney injury
In patients with chronic renal failure with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2, the decision to inject gadoxetate will be based on local contrast policy
Prior negative screening exam less than 5 months prior to enrollment
Prior hepatic resection
Post liver transplantation
Previously treated HCC or other liver neoplasm
Previously enrolled patients to this study
Diagnosis of HCC prior to enrollment in study
Any other condition or factor that in judgment of study investigator may interfere with study completion
Additional locations may be listed on ClinicalTrials.gov for NCT04539717.
I. To determine the diagnostic performance of abbreviated magnetic resonance imaging obtained during the hepatobiliary phase (HBP-AMRI) post gadoxetic acid versus (vs.) ultrasound (US) for hepatocellular carcinoma (HCC) screening in Americans with cirrhosis.
II. To determine the added value of circulating tumor deoxyribonucleic acid (DNA) (ctDNA) and serum alpha-fetoprotein (AFP) for improving HCC detection by HBP-AMRI or US in Americans with cirrhosis.
III. To assess the cost-effectiveness of HBP-AMRI vs. US for HCC screening in Americans with cirrhosis.
EXPLORATORY OBJECTIVE:
I. To assess the diagnostic performance of dynamic abbreviated MRI (Dyn-AMRI) vs HBP-AMRI vs US for HCC screening in Americans with cirrhosis.
OUTLINE:
Patients undergo ultrasound of the liver over 30 minutes and MRI over 1.5 hours.
After completion of study intervention, patients are followed up for 6 months.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationIcahn School of Medicine at Mount Sinai