Hepatocellular CarcinomaNCT03742453
Evaluation of Diagnostic Accuracy of CEUS for HCC Diagnosis
A study testing contrast-enhanced ultrasound and EOB-MRI in people with Hepatocellular Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to compare the diagnostic accuracy of Contrast-enhanced ultrasound (CEUS) for diagnosing hepatocellular carcinoma (HCC) with that of gadoxetic acid-enhanced liver magnetic resonance imaging (MRI) using non-invasive diagnostic criteria (American Association for the Study of Liver Disease (AASLD or Liver… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- contrast-enhanced ultrasound and EOB-MRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Oct 2018to 31 Dec 2021
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High risk group of developing HCC
- hepatic nodule equal to or larger than 1cm on ultrasound or computed tomography (CT)
- newly detected nodule (equal to or larger than 1cm, at least 2cm distance from radiofrequency ablation (RFA) site or resection margin) in patients with history of hepatic resection or RFA for HCC AND in remission more than a year
- scheduled for gadoxetic acid-enhanced liver MRI
- signed informed consent
Who cannot join
- hypersensitivity for ultrasound contrast media
- pregnancy
- history of recent treatment for HCC in a year
- standard of reference is not available
- severe cardiopulmonary disease (right to left shunt, severe pulmonary hypertension, uncontrolled hypertension, etc)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Diagnostic Accuracy of Contrast-enhanced Ultrasound (CEUS) and Gadoxetic Acid-enhanced Liver MRI for Diagnosis of Hepatocellular Carcinoma in Patients With Liver Cirrhosis
This study aims to compare the diagnostic accuracy of Contrast-enhanced ultrasound (CEUS) for diagnosing hepatocellular carcinoma (HCC) with that of gadoxetic acid-enhanced liver magnetic resonance imaging (MRI) using non-invasive diagnostic criteria (American Association for the Study of Liver Disease (AASLD or Liver Imaging Reporting and Data System (LI-RADS) v2018 and Korean Liver Cancer Study Group- National Cancer Center Korea (KLCSG-NCC) v2018).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- contrast-enhanced ultrasound, EOB-MRI
- Keywords
- CEUS, gadoxetic acid, MRI
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contrast-enhanced ultrasoundDiagnostic test
Also called CEUS
CEUS is performed using SonoVue (Bracco, Milan, Italy) intravenous administration in eligible participants within a month before/after EOB-MRI.
EOB-MRIDiagnostic test
Also called gadoxetic acid MRI, Gd-EOB-MRI
EOB-MRI is performed using standard dose of hepatocyte specific contrast media (primovist or eovist) according to standard protocol of our institution.
| Study group | Role | What they receive |
|---|---|---|
| Hepatic nodule group | Experimental | This group meets eligibility criteria, and undergo contrast-enhanced ultrasound (CEUS) and scheduled gadoxetic acid MRI (gadoxetic acid-enhanced liver MRI; EOB-MRI; Gd-EOB-MRI) Receives: Diagnostic Test: contrast-enhanced ultrasound; Diagnostic Test: EOB-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of CEUS for diagnosing HCC
accuracy, sensitivity, specificity of CEUS for HCC diagnosis
Measured: 3 months after CEUS
Secondary outcomes (2)
Diagnostic performance of gadoxetic-acid liver MRI for diagnosing HCC using LI-RADSv2018
accuracy, sensitivity, specificity of MRI using LI-RADS v2018 for HCC diagnosis
Measured: 3 months after MRI
Diagnostic performance of gadoxetic-acid liver MRI for diagnosing HCC using KLCSG-NCC guidelinev2018
accuracy, sensitivity, specificity of MRI using KLCSG-NCC guideline v2018 for HCC diagnosis
Measured: 3 months after MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start16 Oct 2018
- Primary completion26 Aug 2019
- Study completion31 Dec 2021 (estimated)
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.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bracco Corporate
- Responsible party
- Principal investigator, Jeong Min Lee, Seoul National University Hospital
- Investigators
- Jeong Min Lee, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742453
- Sponsor's protocol ID
- SNUH-2018-2268
- Status last verified
- Mar 2021
- First submitted
- 13 Nov 2018
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diagnostic Accuracy of Contrast-enhanced Ultrasound (CEUS) and Gadoxetic Acid-enhanced Liver MRI for Diagnosis of Hepatocellular Carcinoma in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT03742453
- Acronym / sponsor ID
- SNUH-2018-2268
- Conditions
- Hepatocellular Carcinoma
- Keywords
- CEUS, gadoxetic acid, MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Bracco Corporate
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 26 Aug 2019 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 15 Nov 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.
This study aims to compare the diagnostic accuracy of Contrast-enhanced ultrasound (CEUS) for diagnosing hepatocellular carcinoma (HCC) with that of gadoxetic acid-enhanced liver magnetic resonance imaging (MRI) using non-invasive diagnostic criteria (American Association for the Study of Liver Disease (AASLD or Liver Imaging Reporting and Data System (LI-RADS) v2018 and Korean Liver Cancer Study Group- National Cancer Center Korea (KLCSG-NCC) v2018).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatic nodule group | Experimental | Diagnostic Test: contrast-enhanced ultrasound, Diagnostic Test: EOB-MRIThis group meets eligibility criteria, and undergo contrast-enhanced ultrasound (CEUS) and scheduled gadoxetic acid MRI (gadoxetic acid-enhanced liver MRI; EOB-MRI; Gd-EOB-MRI) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- High risk group of developing HCC
- hepatic nodule equal to or larger than 1cm on ultrasound or computed tomography (CT)
- newly detected nodule (equal to or larger than 1cm, at least 2cm distance from radiofrequency ablation (RFA) site or resection margin) in patients with history of hepatic resection or RFA for HCC AND in remission more than a year
- scheduled for gadoxetic acid-enhanced liver MRI
- signed informed consent
Key exclusion criteria (5 listed)
- hypersensitivity for ultrasound contrast media
- pregnancy
- history of recent treatment for HCC in a year
- standard of reference is not available
- severe cardiopulmonary disease (right to left shunt, severe pulmonary hypertension, uncontrolled hypertension, etc)
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 ultrasoundAlso: CEUSCEUS is performed using SonoVue (Bracco, Milan, Italy) intravenous administration in eligible participants within a month before/after EOB-MRI. | Diagnostic test | Hepatic nodule group |
| EOB-MRIAlso: gadoxetic acid MRI, Gd-EOB-MRIEOB-MRI is performed using standard dose of hepatocyte specific contrast media (primovist or eovist) according to standard protocol of our institution. | Diagnostic test | Hepatic nodule group |
Primary outcome
Diagnostic performance of CEUS for diagnosing HCC
Time frame: 3 months after CEUS
accuracy, sensitivity, specificity of CEUS for HCC diagnosis
2 secondary outcomes
Diagnostic performance of gadoxetic-acid liver MRI for diagnosing HCC using LI-RADSv2018
Time frame: 3 months after MRI
Diagnostic performance of gadoxetic-acid liver MRI for diagnosing HCC using KLCSG-NCC guidelinev2018
Time frame: 3 months after MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 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.
Jeong Min Lee, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing contrast-enhanced ultrasound and EOB-MRI in people with Hepatocellular Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
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 5 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: status not confirmed, as of the sponsor's last update on 17 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 South Korea. 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?
Results are not available in the source record.
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 performance of CEUS for diagnosing HCC (time frame: 3 months after CEUS). 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 17 Mar 2021.