FAST (Focused Abbreviated Screening Technique)-MRI Study

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04539717

Collaborator

University of California, San Diego (Other), Duke University (Other), University of Wisconsin, Madison (Other), National Cancer Institute (NCI) (NIH)

820

Enrollment

Location

63.5

Anticipated Duration (Months)

12.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma (HCC) Liver Cirrhosis

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 Design

Study Type:

Observational

Anticipated Enrollment :

820 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Evaluation of Liver Cancer With Magnetic Resonance Imaging (MRI)

Actual Study Start Date :

Aug 17, 2020

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Outcome Measures

Primary Outcome Measures

Presence of HCC [Within 6 months after initial index imaging (MRI & US)]
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029

Sponsors and Collaborators

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

Investigators

Principal Investigator: Bachir Taouli, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bachir Taouli, Professor, Radiology and Medicine, Icahn School of Medicine at Mount Sinai

ClinicalTrials.gov Identifier:

NCT04539717

Other Study ID Numbers:

GCO 19-1409
1R01CA249765-01

First Posted:

Sep 7, 2020

Last Update Posted:

Aug 23, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bachir Taouli, Professor, Radiology and Medicine, Icahn School of Medicine at Mount Sinai

Magnetic Resonance Imaging (MRI)

Ultrasound (US)

Liver Diseases

Elastography

Additional relevant MeSH terms:

Liver Cirrhosis

Study Results

No Results Posted as of Aug 23, 2021