FAST (Focused Abbreviated Screening Technique)-MRI Study

NCT04539717 | Enrolling By Invitation

• 2 other identifiers: GCO 19-14091R01CA249765-01
• Study Type: observational
• Target: 820
• Locations: 1 country
• Sites: 2

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.

Conditions

Hepatocellular Carcinoma (HCC); Liver Cirrhosis

Keywords

Magnetic Resonance Imaging (MRI); Ultrasound (US); Liver Diseases; Elastography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Circulating tumor DNA (ctDNA)

  Within 1 year of blood processing

• Serum AFP

  Within 1 year of blood processing

• Cost-effectiveness

  Within 1 year after initial index imaging (MRI & US).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Liver cirrhosis of any etiology.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• University of California, San Diego: collaborator
• Duke University: collaborator
• University of Wisconsin, Madison: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be collected to measure AFP, AFP-L3 and DCP (Des-carboxy-prothrombin), ctDNA and other tumor markers. The research team will not perform whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen) as part of this study.

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Cirrhosis; Liver Diseases

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bachir Taouli

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Radiology and Medicine

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 7, 2020
• Study Start: August 17, 2020
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)