FAST (Focused Abbreviated Screening Technique)-MRI Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma (HCC), Liver Cirrhosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Abbreviated MRI for HCC Screening in Cirrhotic Patients (FAST-MRI Study)
Overview
The purpose of this study is to compare the diagnostic value of a reconstructed abbreviated Magnetic Resonance Imaging (MRI) from a full clinical exam, compared to ultrasound (US) for screening of liver cancer. Blood markers will be evaluated to determine their correlation to imaging. This study will help to determine whether abbreviated MRI is superior to ultrasound for diagnosis of liver cancer.
Detailed description
Hepatocellular carcinoma (HCC) is the fastest growing cause of cancer death in the United States and now kills over 30,000 Americans annually. To reduce the morbidity and mortality caused by this aggressive cancer, current practice guidelines recommend semi-annual abdominal ultrasound in adults with cirrhosis, the leading risk factor for HCC, to detect HCC nodules when they are small and treatable. Unfortunately, US has poor sensitivity for early-stage HCC in cirrhosis, failing to detect treatable cancer in over half of affected patients. Alternatives such as computed tomography (CT) or magnetic resonance imaging (MRI) are also not ideal due to ionizing radiation (CT), higher cost (MRI), or long exam time (\~30-45 min for MRI). An optimal and fast HCC screening method is urgently needed and should be more sensitive and cost-effective than US and avoid ionizing radiation.
This is a prospective cross-sectional single arm non randomized multicenter study enrolling in 4 American centers as follows: Icahn School of Medicine at Mount Sinai-ISMMS, University of California San Diego-UCSD, University of Wisconsin-UW, and Duke University. The composite reference standard will incorporate the clinical results of the full baseline MRI exam and of subsequent imaging and pathology data collected over the next 6 months. Routine clinical follow-up imaging at 6 months will be observed. Patients will then be classified as positive for HCC, negative for HCC, or excluded.
Primary outcome measures
- Presence of HCC [Time frame: Within 6 months after initial index imaging (MRI & US)]
Secondary outcome measures (3)
- Circulating tumor DNA (ctDNA) [Time frame: Within 1 year of blood processing]
- Serum AFP [Time frame: Within 1 year of blood processing]
- Cost-effectiveness [Time frame: Within 1 year after initial index imaging (MRI & US).]
Eligibility criteria
Inclusion criteria
- Liver cirrhosis of any etiology.
- 18 years of age and older.
- 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.
- Patient is able to give informed consent for this study.
Exclusion criteria
- Contra-indications to MRI.
- Age less than 18 years.
- Patients with chronic renal failure or inability to tolerate contrast.
- Inability to undergo MRI due to lack of insurance coverage.
- Prior negative screening exam less than 5 months prior to enrollment.
- Prior hepatic resection.
- Post liver transplantation.
- Previously treated HCC or other liver neoplasm.
- Any other condition or factor that in judgment of study investigator may interfere with study completion.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 2 centers
- Cedars-Sinai Medical Center — Los Angeles
- Icahn School of Medicine at Mount Sinai — New York
Publications
- Lewis S, Wildman-Tobriner B, Cuevas J, Calle S, Bolger I, Wang K, Joshi H, Mankowski Gettle L, Yang JD, Min JH, Sirlin CB, Reeder SB, Bashir MR, Taouli B. Quality of Gadoxetate-enhanced MRI versus US during Hepatocellular Carcinoma Screening in Participants with Cirrhosis. Radiology. 2026 Feb;318(2):e251497. doi: 10.1148/radiol.251497. PMID 41665498
Identifiers
NCT: NCT04539717 · GCO 19-1409 · 1R01CA249765-01