Liver CirrhosisNCT03318380
Contrast-Enhanced Ultrasound Imaging in Diagnosing Liver Cancer in Patients With Cirrhosis
A study testing Dynamic Contrast-Enhanced Ultrasound Imaging in people with Liver Cirrhosis, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 11 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Dynamic Contrast-Enhanced Ultrasound Imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 612 participants
- Where
- 11 sitesin 6 countries
- Study dates
- 19 Jan 2018to 3 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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
Trial locations and contacts
11 sites in 6 countries.
11 sites in 6 countries
United States6 sites
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Vanderbilt University
Nashville, Tennessee, 37240
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
University of California San Diego
San Diego, California, 92093
Swedish Medical Center
Seattle, Washington, 98104
About this study
Official title: Contrast-Enhanced Ultrasound Evaluation of Focal Liver Lesions in Patients With Cirrhosis or Other Risk Factors for Developing HCC
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Liver Cirrhosis
- Being tested
- Dynamic Contrast-Enhanced Ultrasound Imaging
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Contrast-Enhanced Ultrasound ImagingProcedure or surgery
Undergo CEUS
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Contrast-Enhanced Ultrasound Imaging (CEUS) | Experimental | Patients receive sulfur hexafluoride IV and undergo CEUS imaging over 10 minutes. Receives: Procedure: Dynamic Contrast-Enhanced Ultrasound Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start19 Jan 2018
- Primary completion31 Aug 2021
- Study completion3 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 612 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), GE Healthcare, Bracco Diagnostics, Inc
- Responsible party
- Sponsor
- Investigators
- Andrej Lyshchik, MD, PhD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318380
- Sponsor's protocol ID
- 17F.310
- Other IDs
- JT 10635, 1R01CA215520-01A1
- Status last verified
- May 2025
- First submitted
- 12 Oct 2017
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lyshchik A, Kuon Yeng Escalante C, Siu Xiao T, Piscaglia F, Kono Y, Medellin-Kowalewski A, Rodgers SK, Planz V, Kamaya A, Fetzer DT, Berzigotti A, Radu IP, Sidhu PS, Wessner CE, Bradigan K, Eisenbrey JR, Forsberg F, Wilson SR; CEUS LI-RADS Trial Group; CEUS LI-RADS Trial Group Members. Contrast-enhanced US of High-Risk Indeterminate Focal Liver Observations Categorized as LR-4 or LR-M at CT/MRI. Radiology. 2025 Jan;314(1):e240916. doi: 10.1148/radiol.240916.
PubMed 39835975Kono 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.
PubMed 38860996
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-Enhanced Ultrasound Evaluation of Focal Liver Lesions in Patients With Cirrhosis or Other Risk Factors for Developing HCC
- ClinicalTrials.gov ID
- NCT03318380
- Acronym / sponsor ID
- 17F.310
- Conditions
- Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 612 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), GE Healthcare, Bracco Diagnostics, Inc
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 3 Nov 2022 (actual)
- First posted
- 23 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Contrast-Enhanced Ultrasound Imaging (CEUS) | Experimental | Procedure: Dynamic Contrast-Enhanced Ultrasound ImagingPatients receive sulfur hexafluoride IV and undergo CEUS imaging over 10 minutes. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Contrast-Enhanced Ultrasound ImagingUndergo CEUS | Procedure or surgery | Diagnostic Contrast-Enhanced Ultrasound Imaging (CEUS) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Derived from this study: PubMed 39835975Lyshchik A, Kuon Yeng Escalante C, Siu Xiao T, Piscaglia F, Kono Y, Medellin-Kowalewski A, Rodgers SK, Planz V, Kamaya A, Fetzer DT, Berzigotti A, Radu IP, Sidhu PS, Wessner CE, Bradigan K, Eisenbrey JR, Forsberg F, Wilson SR; CEUS LI-RADS Trial Group; CEUS LI-RADS Trial Group Members. Contrast-enhanced US of High-Risk Indeterminate Focal Liver Observations Categorized as LR-4 or LR-M at CT/MRI. Radiology. 2025 Jan;314(1):e240916. doi: 10.1148/radiol.240916.
- Derived from this study: PubMed 38860996Kono 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.
- Thomas Jefferson University HospitalLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrej Lyshchik, MD, PhD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
11 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Contrast-Enhanced Ultrasound Imaging in people with Liver Cirrhosis, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 11 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Canada, France, Italy, Switzerland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03318380, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.