FAST (Focused Abbreviated Screening Technique)-MRI Study

Status Enrolling by invitation

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04539717
Study type	Observational
Source	Icahn School of Medicine at Mount Sinai
Contact
Status	Enrolling by invitation
Phase
Start date	August 17, 2020
Completion date	December 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04533932` - Endosonographic Shear Wave Elastography for Liver Stiffness
Not yet recruiting	`NCT06031740` - A Comparison of Flexible Endoscopic Polidocanol Liquid and Foam Sclerotherapy in Cirrhotic Patients With Bleeding From Internal Hemorrhoids	N/A
Not yet recruiting	`NCT06026267` - Efficacy of Conventional Dose Protocol vs Low Dose Protocol Albumin Use in Patients With Cirrhosis and High Risk Spontaneous Bacterial Peritonitis	N/A
Not yet recruiting	`NCT06076330` - Efficacy of 5% Albumin v/s Plasmalyte in Combination With 20% Albumin for Fluid Resuscitation in Cirrhosis With Sepsis Induced Hypotension	N/A
Enrolling by invitation	`NCT05055713` - A Randomized Controlled Study on the Treatment of Cirrhosis Combined With Hypersplenism	N/A
Recruiting	`NCT04578301` - Predicting Acute-on-Chronic Liver Failure After Surgical Intervention in Chronic Liver Disease
Not yet recruiting	`NCT05120557` - Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH	N/A
Not yet recruiting	`NCT05515861` - Evaluation of EUS in Preventing Rebleeding After Endoscopic Cyanoacrylate Injection for Gastric Varices	N/A
Not yet recruiting	`NCT02710227` - Sleep Timing and Circadian Preferences in A Sample of Egyptian Patients With Hepatic Cirrhosis	N/A
Not yet recruiting	`NCT03623360` - Functional MRI to Determine Severity of Cirrhosis
Completed	`NCT02917408` - Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital
Active, not recruiting	`NCT02551250` - Annual MRI Versus Biannual US for Surveillance of Hepatocellular Carcinoma in Liver Cirrhosis
Recruiting	`NCT02239991` - Management of Perioperative Coagulopathy With Thromboelastometry (ROTEM) in Liver Transplant	N/A
Enrolling by invitation	`NCT02256514` - Open Label Trial of Immunotherapy for Advanced Liver Cancer	Phase 2
Terminated	`NCT02311985` - Comparison of Three Transfusion Strategies for Central Venous Catheterization in Cirrhotics: A Randomized Clinical Trial	N/A
Terminated	`NCT01937130` - Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF	Phase 2
Recruiting	`NCT01728727` - Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal Stem Cells for Treatment of HBV-related Liver Cirrhosis	Phase 1/Phase 2
Recruiting	`NCT01618890` - Hepatic Venous Pressure Gradient-guided Versus Standard Beta-blocker Therapy in Primary Prevention of Variceal Bleeding	Phase 3
Recruiting	`NCT01724697` - Safety and Efficacy of Human Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis	Phase 1/Phase 2
Recruiting	`NCT01728688` - Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis	Phase 1/Phase 2