FAST (Focused Abbreviated Screening Technique)-MRI Study

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04539717
• Other study ID #: GCO 19-1409
• Secondary ID: 1R01CA249765-01
• Status: Enrolling by invitation
• Start date: August 17, 2020
• Est. completion date: December 2025

Study information

• Verified date: August 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 820
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatocellular Carcinoma (HCC)
• Liver Cirrhosis

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (5)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Duke University, National Cancer Institute (NCI), University of California, San Diego, University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

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