Contrast-Enhanced Ultrasound Imaging in Diagnosing Liver Cancer in Patients With Cirrhosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03318380|
Recruitment Status : Recruiting
First Posted : October 23, 2017
Last Update Posted : December 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Liver Cirrhosis||Procedure: Dynamic Contrast-Enhanced Ultrasound Imaging||Not Applicable|
I. To evaluate the sensitivity, specificity, positive and negative predictive values of contrast-enhanced ultrasound (CEUS) for diagnosis of hepatocellular carcinoma (HCC) in patients at risk for HCC in a multicenter setting.
I. To validate CEUS Liver Imaging Reporting and Data System (LI-RADS) and determine the prevalence of HCC in each CEUS LI-RADS category.
II. To evaluate inter-reader reliability of CEUS for HCC diagnosis. III. To evaluate covariates that might limit diagnostic performance of CEUS for HCC diagnosis.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||640 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Contrast-Enhanced Ultrasound Evaluation of Focal Liver Lesions in Patients With Cirrhosis or Other Risk Factors for Developing HCC|
|Actual Study Start Date :||January 19, 2018|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||March 2022|
Experimental: Diagnostic Contrast-Enhanced Ultrasound Imaging (CEUS)
Patients receive sulfur hexafluoride IV and undergo CEUS imaging over 10 minutes.
Procedure: Dynamic Contrast-Enhanced Ultrasound Imaging
- Sensitivity of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval 95% confidence interval for HCC diagnosis using CEUS LR-5 classification [ Time Frame: Up to 12 months ]A value of 67% for sensitivity is expected based on recent meta-analysis studies of CEUS for focal liver mass characterization.
- Specificity of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval [ Time Frame: Up to 12 months ]A value of 91% for specificity is expected based on recent meta-analysis studies of CEUS for focal liver mass characterization.
- Positive Predictive Value of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval [ Time Frame: Up to 12 months ]A value of 93% for Positive Predicative Value is expected based on recent meta-analysis studies of CEUS for focal liver mass characterization.
- Negative Predictive Value of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval [ Time Frame: Up to 12 months ]A value of 60% for Negative predictive value is expected based on recent meta-analysis studies of CEUS for focal liver mass characterization.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03318380
|Contact: Andrej Lyshchik, MD, PhD||215-503-0587||Andrej.Lyshchik@jefferson.edu|
|United States, California|
|University of California San Diego||Recruiting|
|San Diego, California, United States, 92093|
|Contact: Yuko Kono, MD firstname.lastname@example.org|
|Principal Investigator: Yuko Kono, MD|
|United States, Pennsylvania|
|Sidney Kimmel Cancer Center at Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Andrej Lyshchik, MD, PhD Andrej.Lyshchik@jefferson.edu|
|Albert Einstein Medical Center||Recruiting|
|Philadelphia, Pennsylvania, United States, 19141|
|Contact: Shuchi Rodgers, MD 215-456-3439 rodgersS@einstein.edu|
|Principal Investigator: Shuchi Rodgers, MD|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37240|
|Contact: Geoffrey Wile, MD email@example.com|
|Principal Investigator: Geoffrey Wilde, MD|
|United States, Texas|
|University of Texas Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: David Fetzer, MD David.Fetzer@UTSouthwestern.edu|
|United States, Washington|
|Swedish Medical Center||Terminated|
|Seattle, Washington, United States, 98104|
|University of Calgary||Recruiting|
|Calgary, Canada, T2N 2T9|
|Contact: Stephanie Wilson, MD firstname.lastname@example.org|
|Principal Investigator: Stephanie Wilson, MD|
|University of Paris||Not yet recruiting|
|Contact: Valerie Vilgrain email@example.com|
|University of Bologna||Recruiting|
|Bologna, Italy, 40138|
|Contact: Fabio Piscaglia, MD firstname.lastname@example.org|
|Principal Investigator: Fabio Piscaglia, MD|
|University of Bern||Recruiting|
|Contact: Annalisa Berzigotti Annalisa.Berzigotti@insel.ch|
|King's College Hospital||Recruiting|
|London, United Kingdom|
|Contact: Paul Sidhu, MD email@example.com|
|Principal Investigator: Paul Sidhu|
|Principal Investigator:||Andrej Lyshchik, MD, PhD||Sidney Kimmel Cancer Center at Thomas Jefferson University|