Clinical trial NCT04539717: FAST (Focused Abbreviated Screening Technique)-MRI Study
Official title: Abbreviated MRI for HCC Screening in Cirrhotic Patients (FAST-MRI Study)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hepatocellular Carcinoma (HCC)
Liver Cirrhosis
Keywords: Magnetic Resonance Imaging (MRI)
Ultrasound (US)
Liver Diseases
Elastography
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
name: Duke University
name: University of Wisconsin, Madison
name: National Cancer Institute (NCI)
First posted: 2020-09-07
Enrollment: 820
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosed liver cirrhosis enrolled in imaging-based screening for HCC.

Brief summary: 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.

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.

Primary outcomes:
measure: Presence of HCC
timeFrame: Within 6 months after initial index imaging (MRI & US)
Secondary outcomes:
measure: Circulating tumor DNA (ctDNA)
timeFrame: Within 1 year of blood processing
measure: Serum AFP
timeFrame: Within 1 year of blood processing
measure: Cost-effectiveness
timeFrame: Within 1 year after initial index imaging (MRI & US).
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Bachir Taouli
role: PRINCIPAL_INVESTIGATOR
References: