Contrast-Enhanced Ultrasound Imaging in Diagnosing Liver Cancer in Patients With Cirrhosis
NCT ID: NCT03318380
Last Updated: 2025-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
612 participants
INTERVENTIONAL
2018-01-19
2022-11-03
Brief Summary
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Detailed Description
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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.
SECONDARY OBJECTIVES:
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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic Contrast-Enhanced Ultrasound Imaging (CEUS)
Patients receive sulfur hexafluoride IV and undergo CEUS imaging over 10 minutes.
Dynamic Contrast-Enhanced Ultrasound Imaging
Undergo CEUS
Interventions
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Dynamic Contrast-Enhanced Ultrasound Imaging
Undergo CEUS
Eligibility Criteria
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Inclusion Criteria
* 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.
OR
• 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.
Exclusion Criteria
* 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
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
GE Healthcare
INDUSTRY
Bracco Diagnostics, Inc
INDUSTRY
Sidney Kimmel Cancer Center at Thomas Jefferson University
OTHER
Responsible Party
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Principal Investigators
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Andrej Lyshchik, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Sidney Kimmel Cancer Center at Thomas Jefferson University
Locations
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University of California San Diego
San Diego, California, United States
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States
Vanderbilt University
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Swedish Medical Center
Seattle, Washington, United States
University of Calgary
Calgary, , Canada
University of Paris
Paris, , France
University of Bologna
Bologna, , Italy
University of Bern
Bern, , Switzerland
King's College Hospital
London, , United Kingdom
Countries
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References
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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.
Related Links
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Thomas Jefferson University Hospital
Other Identifiers
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JT 10635
Identifier Type: OTHER
Identifier Source: secondary_id
17F.310
Identifier Type: -
Identifier Source: org_study_id
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