Hepatocellular CarcinomaESCULAPNCT03405909
Standardized CEUS Algorithms for Diagnosis of HCC - Prospective German Multicenter Study
An observational study of Hepatocellular Carcinoma and Cholangiocarcinoma, Intrahepatic, run by University Hospital Erlangen at 1 site in Germany.
Trial summary
Aim of this prospective national multicenter study is to improve standardization of contrast-enhanced ultrasound (CEUS) in the non-invasive diagnosis of hepatocellular carcinoma (HCC) in high-risk patients. The study is funded by the German Society for Ultrasound in Medicine (DEGUM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Cholangiocarcinoma, Intrahepatic, Liver Cirrhosis
- What is being tested?
- contrast enhanced ultrasound (CEUS), MRI and Histology
- How many people
- 517 participants
- Where
- 1 siteGermany
- Study dates
- 21 Apr 2018to 6 Apr 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: High-risk patients for HCC according to German national guidelines (AWMF / DGVS): 1- cirrhosis of any origin; 2- chronic hepatitis B infection; 3 - chronic hepatitis C infection; 4 - non-alcoholic steatohepatitis (NASH); 5 - hereditary hemochromatosis
Who may be able to join
- high risk for HCC
- focal liver lesion on B-mode ultrasound
Who cannot join
- pre-treated HCC lesion
- systemic therapy for HCC (sorafenib, regorafenib and others)
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Erlangen, Department of Medicine 1
Erlangen, Bavaria, 91054
About this study
Official title: Standardized Contrast-enhanced Ultrasound (CEUS) -Algorithms for the Non-invasive Diagnosis of Hepatocellular Carcinoma (HCC) in High-risk-patients - a Prospective German Multicenter Study
Aim of this prospective national multicenter study is to improve standardization of contrast-enhanced ultrasound (CEUS) in the non-invasive diagnosis of hepatocellular carcinoma (HCC) in high-risk patients.
The study is funded by the German Society for Ultrasound in Medicine (DEGUM).
Read the detailed description
To date, CEUS criteria for non-invasive diagnosis of HCC include arterial phase hyperenhancement, followed by contrast washout in the portal venous or late phase. We would like to investigate the following points:
- whether arterial hyperenhancement alone is sufficient for the definite diagnosis of HCC in cirrhosis with CEUS
- whether a further clearly-defined point of assessment in the late phase after 4-6 minutes is of additional diagnostic value in focal liver lesions showing no contrast washout after 3 minutes
- diagnostic value of CEUS-based standardised diagnostic algorithms (ESCULAP = Erlanger Synopsis of Contrast Enhanced Ultrasound for Liver lesion Assessment in Patients at risk; CEUS LI-RADS = Contrast Enhanced Ultrasound Liver Imaging Reporting and Data System) for non-invasive diagnosis of HCC in high-risk patients (diagnostic accuracy, interobserver-variability, feasability in clinical Routine).
- Conditions
- Hepatocellular Carcinoma, Cholangiocarcinoma, Intrahepatic, Liver Cirrhosis, Liver Cancer, Liver Neoplasms, Liver Diseases
- Being tested
- contrast enhanced ultrasound (CEUS), MRI, Histology
- Keywords
- contrast-enhanced ultrasound, non-invasive diagnosis, focal liver lesion, liver cirrhosis, standardised diagnostic algorithm, intrahepatic cholangiocellular carcinoma, ESCULAP, CEUS LI-RADS, imaging, hepatocellular carcinoma, MRI, diagnostic accuracy, interobserver agreement, Erlanger Synopsis of CEUS for Liver lesion Assessment in Patients at risk, CEUS Liver Imaging Reporting and Data System
- Medical subject headings
- Carcinoma, Hepatocellular, Cholangiocarcinoma, Liver Cirrhosis, Liver Neoplasms, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contrast enhanced ultrasound (CEUS)Diagnostic test
CEUS with SonoVue following standardized protocol
MRIDiagnostic test
CE-MRI following standardized protocol
HistologyDiagnostic test
diagnostic liver biopsy
| Study group | Role | What they receive |
|---|---|---|
| Patients at risk for HCC | Patients with any of the following conditions:
liver cirrhosis of any origin chronic hepatitis B infection chronic hepatitis C infection with advanced fibrosis non-alcoholic steatohepatitis (NASH) hemochromatosis
Interventions: B-mode ultrasound, contrast enhanced ultrasound (CEUS); MRI / histology Receives: Diagnostic Test: contrast enhanced ultrasound (CEUS); Diagnostic Test: MRI; Diagnostic Test: Histology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic value of standardised CEUS-based algorithms for the non-invasive diagnosis of HCC in high-risk patients
Diagnostic accuracy, interobserver-variabilty and feasability in clinical routine for CEUS-based algorithms Reference Standard: histology / MRI
Measured: 2 years
Secondary outcomes (6)
Diagnostic value / dispensability of contrast washout for definite diagnosis of HCC with CEUS
Sensitvity, specificity, positive and negative predictive value of arterial hyperenhancement only compared with arterial hyperenhancement followed by contrast washout for non-invasive diagnosis of HCC in high-risk patients Reference Standard: histology / MRI
Measured: 2 years
Standardisation of CEUS examinations
Diagnostic value of an additional standardised examination point in the late phase after 4-6 minutes in lesions without contrast washout after 3 minutes Reference Standard: histology / MRI
Measured: 2 years
Diagnostic accuracy of CEUS in intrahepatic cholangiocellular carcinoma (ICC)
Sensitvity, specificity, positive and negative predictive value of contrast-enhanced ultrasound for non-invasive diagnosis of ICC in high-risk patients / differential diagnosis of HCC versus ICC Reference Standard: histology
Measured: 2 years
Comparison of two CEUS-based algorithms
ESCULAP versus CEUS LI-RADS (diagnostic accuracy, interobserver agreement) Reference Standard: histology / MRI
Measured: 2 years
Non-inferiority of CEUS versus MRI for non-invasive diagnosis of HCC
Comparison of CEUS and MRI for non-invasive diagnosis of HCC (diagnostic accuracy, interobserver agreement) Reference Standard: histology
Measured: 2 years
Influence of histological grading on contrast enhancement behaviour
correlation of histological grading and contrast enhancement pattern
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start21 Apr 2018
- Primary completion6 Apr 2019
- Study completion6 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 517 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Erlangen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Barbara Schellhaas and Prof. Dr. med. Deike Strobel, University Hospital Erlangen
- Investigators
- Barbara Schellhaas, MD, Principal investigator, University Hospital Erlangen, Department of Medicine 1Deike Strobel, MD, Principal investigator, University Hospital Erlangen, Department of Medicine 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405909
- Sponsor's protocol ID
- DEGUM CEUS HCC
- Acronym
- ESCULAP
- Status last verified
- Feb 2021
- First submitted
- 12 Jan 2018
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized Contrast-enhanced Ultrasound (CEUS) -Algorithms for the Non-invasive Diagnosis of Hepatocellular Carcinoma (HCC) in High-risk-patients - a Prospective German Multicenter Study
- ClinicalTrials.gov ID
- NCT03405909
- Acronym / sponsor ID
- ESCULAP / DEGUM CEUS HCC
- Conditions
- Hepatocellular Carcinoma, Cholangiocarcinoma, Intrahepatic, Liver Cirrhosis, Liver Cancer, Liver Neoplasms, Liver Diseases
- Keywords
- contrast-enhanced ultrasound, non-invasive diagnosis, focal liver lesion, liver cirrhosis, standardised diagnostic algorithm, intrahepatic cholangiocellular carcinoma, ESCULAP, CEUS LI-RADS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 517 participants (actual)
- Lead sponsor
- University Hospital ErlangenUniversity, hospital or other
- Study start
- 21 Apr 2018 (actual)
- Primary completion
- 6 Apr 2019 (actual)
- Study completion
- 6 Apr 2019 (actual)
- First posted
- 23 Jan 2018 (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.
Aim of this prospective national multicenter study is to improve standardization of contrast-enhanced ultrasound (CEUS) in the non-invasive diagnosis of hepatocellular carcinoma (HCC) in high-risk patients.
The study is funded by the German Society for Ultrasound in Medicine (DEGUM).
Detailed description
To date, CEUS criteria for non-invasive diagnosis of HCC include arterial phase hyperenhancement, followed by contrast washout in the portal venous or late phase. We would like to investigate the following points:
- whether arterial hyperenhancement alone is sufficient for the definite diagnosis of HCC in cirrhosis with CEUS
- whether a further clearly-defined point of assessment in the late phase after 4-6 minutes is of additional diagnostic value in focal liver lesions showing no contrast washout after 3 minutes
- diagnostic value of CEUS-based standardised diagnostic algorithms (ESCULAP = Erlanger Synopsis of Contrast Enhanced Ultrasound for Liver lesion Assessment in Patients at risk; CEUS LI-RADS = Contrast Enhanced Ultrasound Liver Imaging Reporting and Data System) for non-invasive diagnosis of HCC in high-risk patients (diagnostic accuracy, interobserver-variability, feasability in clinical Routine).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients at risk for HCC | – | Diagnostic Test: contrast enhanced ultrasound (CEUS), Diagnostic Test: MRI, Diagnostic Test: HistologyPatients with any of the following conditions: liver cirrhosis of any origin chronic hepatitis B infection chronic hepatitis C infection with advanced fibrosis non-alcoholic steatohepatitis (NASH) hemochromatosis Interventions: B-mode ultrasound, contrast enhanced ultrasound (CEUS); MRI / histology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- High-risk patients for HCC according to German national guidelines (AWMF / DGVS): 1- cirrhosis of any origin; 2- chronic hepatitis B infection; 3 - chronic hepatitis C infection; 4 - non-alcoholic steatohepatitis (NASH); 5 - hereditary hemochromatosis
Key inclusion criteria (2 listed)
- high risk for HCC
- focal liver lesion on B-mode ultrasound
Key exclusion criteria (2 listed)
- pre-treated HCC lesion
- systemic therapy for HCC (sorafenib, regorafenib and others)
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 |
|---|---|---|
| contrast enhanced ultrasound (CEUS)CEUS with SonoVue following standardized protocol | Diagnostic test | Patients at risk for HCC |
| MRICE-MRI following standardized protocol | Diagnostic test | Patients at risk for HCC |
| Histologydiagnostic liver biopsy | Diagnostic test | Patients at risk for HCC |
Primary outcome
Diagnostic value of standardised CEUS-based algorithms for the non-invasive diagnosis of HCC in high-risk patients
Time frame: 2 years
Diagnostic accuracy, interobserver-variabilty and feasability in clinical routine for CEUS-based algorithms Reference Standard: histology / MRI
6 secondary outcomes
Diagnostic value / dispensability of contrast washout for definite diagnosis of HCC with CEUS
Time frame: 2 years
Standardisation of CEUS examinations
Time frame: 2 years
Diagnostic accuracy of CEUS in intrahepatic cholangiocellular carcinoma (ICC)
Time frame: 2 years
Comparison of two CEUS-based algorithms
Time frame: 2 years
Non-inferiority of CEUS versus MRI for non-invasive diagnosis of HCC
Time frame: 2 years
Influence of histological grading on contrast enhancement behaviour
Time frame: 2 years
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 2 Mar 2021.
- 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.
Barbara Schellhaas, MD principal investigator
University Hospital Erlangen, Department of Medicine 1
Deike Strobel, MD principal investigator
University Hospital Erlangen, Department of Medicine 1
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Cholangiocarcinoma, Intrahepatic, run by University Hospital Erlangen at 1 site in Germany.
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 2 inclusion and 2 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 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Diagnostic value of standardised CEUS-based algorithms for the non-invasive diagnosis of HCC in high-risk patients (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2021.