FAST (Focused Abbreviated Screening Technique)-MRI Study

Abbreviated MRI for HCC Screening in Cirrhotic Patients (FAST-MRI Study)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Liver Cirrhosis; Hepatocellular Carcinoma (HCC)

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.

• Study Type: Observational
• Enrollment (Estimated): 820

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosed liver cirrhosis enrolled in imaging-based screening for HCC.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of HCC	The presence of HCC will be determined by a composite reference standard. This composite reference standard incorporates the results of the complete MRI exam, pathology, and clinical follow-up.	Within 6 months after initial index imaging (MRI & US)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circulating tumor DNA (ctDNA)		Within 1 year of blood processing
Serum AFP	Serum Alpha-Fetoprotein	Within 1 year of blood processing
Cost-effectiveness	The cost-effectiveness will be assessed using a micro simulation model.	Within 1 year after initial index imaging (MRI & US).

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Cancer Institute (NCI); University of California, San Diego; University of Wisconsin, Madison; Duke University
• Investigators: Principal Investigator: Bachir Taouli, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2020
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (Actual): September 7, 2020

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Liver Diseases; Elastography; Magnetic Resonance Imaging (MRI); Ultrasound (US)
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: GCO 19-1409; 1R01CA249765-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No