FAST (Focused Abbreviated Screening Technique)-MRI Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

820 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-17

Study Completion Date

2026-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Non-contrast Abbreviated MRI for Secondary Surveillance of HCC

NCT05690451

Hepatocellular Carcinoma

COMPLETED

Gadolinium Contrast-enhanced Abbreviated MRI (AMRI) Vs. Standard Ultrasound for Hepatocellular Carcinoma (HCC) Surveillance in Patients with Cirrhosis

NCT04288323

Liver Cancer Liver Cirrhoses Liver Carcinoma

RECRUITING PHASE4

FAST-IRM for HCC suRveillance in pAtients With High risK of Liver Cancer.

NCT05095714

Hepatocellular Carcinoma Liver Cancer Cirrhosis +1 more

NOT_YET_RECRUITING NA

Abbreviated MRI for HCC Surveillance

NCT03731923

Hepatocellular Carcinoma Liver Cirrhosis Chronic Hepatitis

UNKNOWN NA

Screening for Liver Cancer With CT vs. Ultrasound in Patients With Advanced Liver Disease

NCT01350167

Cirrhosis End Stage Liver Disease Hepatitis C

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatocellular Carcinoma (HCC) Liver Cirrhosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No