Liver CirrhosisNCT06312826
Abbreviated MRI Using Gadoxetic Acid Versus Ultrasonography for Surveillance of Early-stage HCC in Patients at High Risk
A study testing Abdominal US and AMRI in people with Liver Cirrhosis and Hepatocellular Carcinoma, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Hepatocellular carcinoma (HCC) is the third most frequent cause of cancer-related deaths worldwide. The incidence of HCC has been rapidly rising worldwide over the last two decades. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Liver Cirrhosis, Hepatocellular Carcinoma
- What is being tested?
- Abdominal US and AMRI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 806 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Aug 2022to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients with liver cirrhosis who are classified as high-risk for HCC "High-risk for HCC" is defined as exceeding 2.33 according to the following formula, taking into consideration previous research results: Risk Index = 1.65 (if the prothrombin activity is ≤75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is <100 x 10^3/mm^3) + 0.74 (if the presence of anti-HCV or HBsAg is positive)
- Liver cirrhosis is diagnosed when it occurs within the 12 months prior to the research examination, regardless of the cause. The diagnostic criteria for liver cirrhosis are as follows:
- Diagnosis of liver cirrhosis histologically by liver tissue examination, Showing a value of 12 kPa or higher in liver stiffness measurement (fibroscan), Showing typical features of liver cirrhosis on imaging examination or evidence of portal hypertension such as splenomegaly or varices on imaging examination.
- Absence of previous or current history o f HCC within 6 months prior to screening
- Eastern Cooperative Oncology Group performance status of 0-2
- Patient is able to comply with scheduled visits, evaluation plans, and other study procedures
- Patient is willing to provide written informed consent
Who cannot join
- Active or suspected cancer, or a history of malignancy where the risk of recurrence is equal or higher than 20% within 2 years.
- Significant medical comorbidities in which survival is predicted to be less than 3 years
- Estimated glomerular filtration rate < 30 mL/min/1.73m²
- Patient not eligible for applying LI-RADS criteria, such as Budd-Chiari Syndrome
- Precautions for MRI (cardiac pacemaker, severe claustrophobia that may interfere with protocol compliance).
- Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrollment or could interfere with completing the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Comparative Cohort Study to Investigate Abbreviated Magnetic Resonance Imaging Using Gadoxetic Acid and Ultrasonography for Surveillance of Early-stage HCC in Patients at High Risk for HCC
Hepatocellular carcinoma (HCC) is the third most frequent cause of cancer-related deaths worldwide. The incidence of HCC has been rapidly rising worldwide over the last two decades. In order to improve survival with curative treatment, regular surveillance to detect early-stage HCC is recommended for at-risk populations. Although ultrasonography (US) has been endorsed as the primary surveillance tool for HCC, a recent meta-analysis found that US has a sensitivity of 47% for detecting early-stage HCC, and its sensitivity for detecting early-stage HCC has been questioned. Many recent studies have explored the potential of alternative surveillance tools for HCC other than US, particularly for high-risk patients. Although complete gadoxetic acid-enhanced magnetic resonance imaging (MRI) demonstrated excellent performance, its high cost and long examination time can hamper its widespread adoption. Abbreviated MRI (AMRI) including hepatobiliary-phase imaging is a promising option to detect potential indicators of HCC, maintaining the benefits of highly sensitive imaging while reducing the examination time by omitting dynamic contrast-enhanced imaging. Because US is the current primary surveillance tool for HCC, this new surveillance tool must be compared with US in a prospective randomized comparative design.
Thus, the hypothesis to be proved in this study is as follows: AMRI with gadoxetic acid will show a significantly higher detection rate compared to US for the detection of early-stage HCC in patients with cirrhosis and at high risk of developing HCC, defined as an estimated annual HCC risk of higher than 5%. We will also analyze whether the false-referral rate of AMRI with gadoxetic acid is not compromised by its high detection rate.
Read the detailed description
A total of 806 subjects will be randomized in a 1:1 ratio into the US group and the AMRI group. Subjects will be evaluated by two rounds of tests with US or AMRI at intervals of 6 months. After the completion of the two evaluation rounds, at least 6 months of clinical follow-up data will be collected to record the occurrence of interval cancer.
US group: Subjects will be evaluated by two rounds of tests with abdominal US for the surveillance of HCC at intervals of 6 months.
AMRI group: Subjects will be evaluated by two rounds of tests with AMRI with gadoxetic acid for the surveillance of HCC at intervals of 6 months.
- Conditions
- Liver Cirrhosis, Hepatocellular Carcinoma
- Being tested
- Abdominal US, AMRI
- Medical subject headings
- Liver Cirrhosis, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal USProcedure or surgery
The acquired images included B-mode images of the left hepatic lobe through transverse and longitudinal scans including images of the umbilical portion of the left portal vein, and images of the right hepatic lobe through subcostal and intercostal scans including images of the right hepatic dome, right portal vein, and right hepatic vein with additional images of the confluence of both portal vein and three hepatic veins. When a liver observation was seen, additional images were taken, and its diameter was measured on both transverse and longitudinal planes.
AMRIProcedure or surgery
The study subjects receive intravenous injection of gadoxetic acid (0.025 mmol/kg, Primovist; Bayer, Berlin, Germany) in the waiting room and then proceed to the examination room for MRI testing 15-20 minutes later. The MRI examination is conducted using a 3T MRI machine, and the MRI protocol consists of T2-weighted imaging, diffusion-weighted imaging (b value of 0, 50, and 500 s/mm2), and hepatobiliary phase imaging.
| Study group | Role | What they receive |
|---|---|---|
| US group | Active comparator | Subjects will be evaluated by two rounds of tests with abdominal US for the surveillance of HCC at intervals of 6 months. Receives: Procedure: Abdominal US |
| AMRI group | Experimental | Subjects will be evaluated by two rounds of tests with AMRI for the surveillance of HCC at intervals of 6 months. Receives: Procedure: AMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of patients with early stage HCC
Detection rate = TP / TP + FP +TN + FN
Measured: 6 months after the completion of the 2 surveillance rounds
Secondary outcomes (6)
False referral rate of patients with early stage HCC
False referral rate = FP / TP +FP +TN + FN
Measured: 6 months after the completion of the 2 surveillance rounds
Detection rate of patients with very early stage HCC
Detection rate = TP / TP + FP +TN + FN
Measured: 6 months after the completion of the 2 surveillance rounds
False referral rate of patients with very early stage HCC
False referral rate = FP / TP +FP +TN + FN
Measured: 6 months after the completion of the 2 surveillance rounds
Detection rate of patients with all-stage HCC
Detection rate = TP / TP + FP +TN + FN
Measured: 6 months after the completion of the 2 surveillance rounds
False referral rate of patients with all-stage HCC
False referral rate = FP / TP +FP +TN + FN
Measured: 6 months after the completion of the 2 surveillance rounds
Stage distribution at initial HCC diagnosis
Distribution of BCLC stage (0, A, B, and C)
Measured: At the time of diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start26 Aug 2022
- Primary completionNov 2025 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 806 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, So Yeon Kim, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312826
- Sponsor's protocol ID
- KCT0007417
- Other IDs
- 2022-0661
- Status last verified
- May 2025
- First submitted
- 9 Mar 2024
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park HJ, Choi J, Kim DW, Choi SH, Choi WM, Chung SW, Lee D, Shim JH, Lee HC, Lim YS, Kim MJ, Singal AG, Park SH, Kim SY. Abbreviated gadoxetic acid-enhanced MRI versus ultrasonography for HCC surveillance in high-risk patients: A randomized trial protocol. Hepatol Commun. 2025 Dec 1;9(12):e0839. doi: 10.1097/HC9.0000000000000839. eCollection 2025 Dec 1.
PubMed 41481895
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Comparative Cohort Study to Investigate Abbreviated Magnetic Resonance Imaging Using Gadoxetic Acid and Ultrasonography for Surveillance of Early-stage HCC in Patients at High Risk for HCC
- ClinicalTrials.gov ID
- NCT06312826
- Acronym / sponsor ID
- KCT0007417
- Conditions
- Liver Cirrhosis, Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 806 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Mar 2024 (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.
Hepatocellular carcinoma (HCC) is the third most frequent cause of cancer-related deaths worldwide. The incidence of HCC has been rapidly rising worldwide over the last two decades. In order to improve survival with curative treatment, regular surveillance to detect early-stage HCC is recommended for at-risk populations. Although ultrasonography (US) has been endorsed as the primary surveillance tool for HCC, a recent meta-analysis found that US has a sensitivity of 47% for detecting early-stage HCC, and its sensitivity for detecting early-stage HCC has been questioned. Many recent studies have explored the potential of alternative surveillance tools for HCC other than US, particularly for high-risk patients. Although complete gadoxetic acid-enhanced magnetic resonance imaging (MRI) demonstrated excellent performance, its high cost and long examination time can hamper its widespread adoption. Abbreviated MRI (AMRI) including hepatobiliary-phase imaging is a promising option to detect potential indicators of HCC, maintaining the benefits of highly sensitive imaging while reducing the examination time by omitting dynamic contrast-enhanced imaging. Because US is the current primary surveillance tool for HCC, this new surveillance tool must be compared with US in a prospective randomized comparative design.
Thus, the hypothesis to be proved in this study is as follows: AMRI with gadoxetic acid will show a significantly higher detection rate compared to US for the detection of early-stage HCC in patients with cirrhosis and at high risk of developing HCC, defined as an estimated annual HCC risk of higher than 5%. We will also analyze whether the false-referral rate of AMRI with gadoxetic acid is not compromised by its high detection rate.
Detailed description
A total of 806 subjects will be randomized in a 1:1 ratio into the US group and the AMRI group. Subjects will be evaluated by two rounds of tests with US or AMRI at intervals of 6 months. After the completion of the two evaluation rounds, at least 6 months of clinical follow-up data will be collected to record the occurrence of interval cancer.
US group: Subjects will be evaluated by two rounds of tests with abdominal US for the surveillance of HCC at intervals of 6 months.
AMRI group: Subjects will be evaluated by two rounds of tests with AMRI with gadoxetic acid for the surveillance of HCC at intervals of 6 months.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| US group | Active comparator | Procedure: Abdominal USSubjects will be evaluated by two rounds of tests with abdominal US for the surveillance of HCC at intervals of 6 months. |
| AMRI group | Experimental | Procedure: AMRISubjects will be evaluated by two rounds of tests with AMRI for the surveillance of HCC at intervals of 6 months. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with liver cirrhosis who are classified as high-risk for HCC "High-risk for HCC" is defined as exceeding 2.33 according to the following formula, taking into consideration previous research results: Risk Index = 1.65 (if the prothrombin activity is ≤75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is <100 x 10^3/mm^3) + 0.74 (if the presence of anti-HCV or HBsAg is positive)
- Liver cirrhosis is diagnosed when it occurs within the 12 months prior to the research examination, regardless of the cause. The diagnostic criteria for liver cirrhosis are as follows:
- Diagnosis of liver cirrhosis histologically by liver tissue examination, Showing a value of 12 kPa or higher in liver stiffness measurement (fibroscan), Showing typical features of liver cirrhosis on imaging examination or evidence of portal hypertension such as splenomegaly or varices on imaging examination.
- Absence of previous or current history o f HCC within 6 months prior to screening
- Eastern Cooperative Oncology Group performance status of 0-2
Key exclusion criteria (6 listed)
- Active or suspected cancer, or a history of malignancy where the risk of recurrence is equal or higher than 20% within 2 years.
- Significant medical comorbidities in which survival is predicted to be less than 3 years
- Estimated glomerular filtration rate < 30 mL/min/1.73m²
- Patient not eligible for applying LI-RADS criteria, such as Budd-Chiari Syndrome
- Precautions for MRI (cardiac pacemaker, severe claustrophobia that may interfere with protocol compliance).
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 |
|---|---|---|
| Abdominal USThe acquired images included B-mode images of the left hepatic lobe through transverse and longitudinal scans including images of the umbilical portion of the left portal vein, and images of the right hepatic lobe through subcostal and intercostal scans including images of the right hepatic dome, right portal vein, and right hepatic vein with additional images of the confluence of both portal vein and three hepatic veins. When a liver observation was seen, additional images were taken, and its diameter was measured on both transverse and longitudinal planes. | Procedure or surgery | US group |
| AMRIThe study subjects receive intravenous injection of gadoxetic acid (0.025 mmol/kg, Primovist; Bayer, Berlin, Germany) in the waiting room and then proceed to the examination room for MRI testing 15-20 minutes later. The MRI examination is conducted using a 3T MRI machine, and the MRI protocol consists of T2-weighted imaging, diffusion-weighted imaging (b value of 0, 50, and 500 s/mm2), and hepatobiliary phase imaging. | Procedure or surgery | AMRI group |
Primary outcome
Detection rate of patients with early stage HCC
Time frame: 6 months after the completion of the 2 surveillance rounds
Detection rate = TP / TP + FP +TN + FN
6 secondary outcomes
False referral rate of patients with early stage HCC
Time frame: 6 months after the completion of the 2 surveillance rounds
Detection rate of patients with very early stage HCC
Time frame: 6 months after the completion of the 2 surveillance rounds
False referral rate of patients with very early stage HCC
Time frame: 6 months after the completion of the 2 surveillance rounds
Detection rate of patients with all-stage HCC
Time frame: 6 months after the completion of the 2 surveillance rounds
False referral rate of patients with all-stage HCC
Time frame: 6 months after the completion of the 2 surveillance rounds
Stage distribution at initial HCC diagnosis
Time frame: At the time of diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Derived from this study: PubMed 41481895Park HJ, Choi J, Kim DW, Choi SH, Choi WM, Chung SW, Lee D, Shim JH, Lee HC, Lim YS, Kim MJ, Singal AG, Park SH, Kim SY. Abbreviated gadoxetic acid-enhanced MRI versus ultrasonography for HCC surveillance in high-risk patients: A randomized trial protocol. Hepatol Commun. 2025 Dec 1;9(12):e0839. doi: 10.1097/HC9.0000000000000839. eCollection 2025 Dec 1.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal US and AMRI in people with Liver Cirrhosis and Hepatocellular Carcinoma, run by Asan Medical Center 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 7 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 31 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Detection rate of patients with early stage HCC (time frame: 6 months after the completion of the 2 surveillance rounds). 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 NCT06312826, which also lists 1 linked publication.
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 31 May 2025.