NCT03318380

Brief Summary

This clinical trial studies how well contrast-enhanced ultrasound imaging works in diagnosing liver cancer in patients with cirrhosis. Diagnostic procedures, such as contrast-enhanced ultrasound imaging, may help find and diagnose liver cancer.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
612

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
6 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 23, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

January 19, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2022

Completed
Last Updated

May 18, 2025

Status Verified

May 1, 2025

Enrollment Period

3.6 years

First QC Date

October 12, 2017

Last Update Submit

May 14, 2025

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (4)

  • 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

    A value of 67% for sensitivity is expected based on recent meta-analysis studies of CEUS for focal liver mass characterization.

    Up to 12 months

  • Specificity of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval

    A value of 91% for specificity is expected based on recent meta-analysis studies of CEUS for focal liver mass characterization.

    Up to 12 months

  • Positive Predictive Value of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval

    A value of 93% for Positive Predicative Value is expected based on recent meta-analysis studies of CEUS for focal liver mass characterization.

    Up to 12 months

  • Negative Predictive Value of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval

    A value of 60% for Negative predictive value is expected based on recent meta-analysis studies of CEUS for focal liver mass characterization.

    Up to 12 months

Study Arms (1)

Diagnostic Contrast-Enhanced Ultrasound Imaging (CEUS)

EXPERIMENTAL

Patients receive sulfur hexafluoride IV and undergo CEUS imaging over 10 minutes.

Procedure: Dynamic Contrast-Enhanced Ultrasound Imaging

Interventions

Dynamic Contrast-Enhanced Ultrasound ImagingPROCEDURE

Undergo CEUS

Diagnostic Contrast-Enhanced Ultrasound Imaging (CEUS)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Capable of making informed decisions regarding his/her treatment
  • Have known cirrhosis or other risk factors for HCC, based on American Association for the Study of Liver Diseases (AASLD) and European Association for the Study of the Liver (EASL) guidelines (applicable in each site jurisdictions)
  • Patients with untreated focal liver observations on liver ultrasound or multiphase contrast-enhanced CT or MRI performed as part of clinical standard of care within 4 weeks before patient enrollment.
  • Patients with untreated focal liver observations scheduled for follow-up multiphase contrast-enhanced CT or MRI, biopsy or surgical excision as part of clinical standard of care. CEUS should be performed within 4 weeks before or after follow-up imaging or within 4 weeks before biopsy or surgical excision.

You may not qualify if:

  • Patients who are pregnant or lactating
  • Patients with focal liver observations less than 5 mm or greater than 5 cm in size
  • Patients with contraindications to CEUS
  • Patients with contraindications to both CT and MRI
  • Patients who are medically unstable, terminally ill, or whose clinical course is unpredictable
  • Liver nodule previously treated with trans-arterial or thermal ablation
  • Patients who have received an investigational drug in the 30 days before CEUS, or will receive one within 72 hour after their CEUS exam

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University of California San Diego

San Diego, California, 92093, United States

Location

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

Vanderbilt University

Nashville, Tennessee, 37240, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Swedish Medical Center

Seattle, Washington, 98104, United States

Location

University of Calgary

Calgary, T2N 2T9, Canada

Location

University of Paris

Paris, France

Location

University of Bologna

Bologna, 40138, Italy

Location

University of Bern

Bern, Switzerland

Location

King's College Hospital

London, United Kingdom

Location

Related Publications (1)

  • Kono Y, Piscaglia F, Wilson SR, Medellin A, Rodgers SK, Planz V, Kamaya A, Fetzer DT, Berzigotti A, Sidhu PS, Wessner CE, Bradigan K, Kuon Yeng Escalante CM, Siu Xiao T, Eisenbrey JR, Forsberg F, Lyshchik A; CEUS LI-RADS Trial Group. Clinical impact of CEUS on non-characterizable observations and observations with intermediate probability of malignancy on CT/MRI in patients at risk for HCC. Abdom Radiol (NY). 2024 Aug;49(8):2639-2649. doi: 10.1007/s00261-024-04305-9. Epub 2024 Jun 11.

    PMID: 38860996DERIVED

Related Links

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Andrej Lyshchik, MD, PhD

    Sidney Kimmel Cancer Center at Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2017

First Posted

October 23, 2017

Study Start

January 19, 2018

Primary Completion

August 31, 2021

Study Completion

November 3, 2022

Last Updated

May 18, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)IT(1)GB(1)CA(1)US(6)FR(1)