Hepatocellular CarcinomaNCT06537193
Abbreviated MRI Using Gadoxetic Acid Versus CT for Surveillance of Recurrent HCC After Curative Treatment
A study testing AMRI and CT in people with Hepatocellular Carcinoma, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Hepatocellular carcinoma (HCC) often has a poor prognosis after curative treatment due to frequent recurrence. Post-surgery, 60-70% of HCC patients experience recurrence, rising to 80% after ablation therapy. 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?
- AMRI and CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 455 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Dec 2024to 31 Dec 2028
- 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 more than two years without recurrence after curative treatment (surgery or local ablation) for HCC
- Patients with no history of systemic treatment, radiation therapy, or trans-arterial chemoembolization for HCC
- Older than 20 years of age
- 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
- Child-Pugh class C
- Patient not eligible for applying LI-RADS criteria, such as Budd-Chiari Syndrome
- Previous history of severe allergic reaction to iodine contrast medium
- 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. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, Songpa-gu , 88, Olympic-ro 43-gil, 05505
So Yeon Kim, MD, PhD, 82-2-3010-5980, sykim.radiology@gmail.com
Hyo Jung Park, MD, PhD, 82-2-3010-0627, happyeahj@gmail.com
About this study
Official title: A Prospective Multicenter Study for the Intra-Individual Comparison of Abbreviated MRI Using Gadoxetic Acid and Dynamic CT for Surveillance of Recurrent HCC After Curative Treatment
Hepatocellular carcinoma (HCC) often has a poor prognosis after curative treatment due to frequent recurrence. Post-surgery, 60-70% of HCC patients experience recurrence, rising to 80% after ablation therapy. This is partly because underlying cirrhosis or chronic liver disease remains, increasing the risk of secondary HCC. The risk of recurrence varies over time, with a high risk in the first two years due to micro-metastasis. Later recurrences are usually new primary cancers (de novo HCC). Therefore, regular imaging tests, such as computed tomography (CT) or magnetic resonance imaging (MRI) every three months in the first two years, are necessary for early detection, but guidelines for post-two-year screenings are unclear.
Currently, for patients recurrence-free for two years, contrast-enhanced liver CT or MRI is performed every 3-6 months as a secondary screening test. However, repeated use of CT raises concerns about radiation exposure and iodine-based contrast agents can lead to side effects and kidney issues. MRI with hepatocyte-specific agents like gadoxetic acid (Primovist) is effective but costly and time-consuming, with potential side effects from repeated gadolinium exposure. Therefore, there is a need for a validated secondary screening method that is both effective and reduces patient risk.
Abbreviated contrast-enhanced MRI, using only essential sequences, has shown promise in retrospective studies for detecting HCC. However, these studies have limitations, such as potential bias and lack of data on repeated screenings. There is limited research on secondary screening post-curative treatment for HCC. This study aims to prospectively evaluate the use of abbreviated contrast-enhanced MRI with Primovist as a secondary screening method for detecting secondary HCC in patients who have been recurrence-free for more than two years.
Read the detailed description
A total of 455 subjects will be evaluated by two rounds of tests with both abbreviated MRI (AMRI) and dynamic CT to detect the occurrence of secondary HCC. These two imaging tests are planned to be performed twice, with a basic interval of 16 weeks between tests. However, considering the clinical practice of varying the imaging intervals based on the patient's risk level, the actual interval between tests can range from 4 to 8 months. If a suspicious lesion indicative of HCC is detected during the study, a recall examination using complete MRI will be performed within 3 months. If the recall examination does not confirm the diagnosis, a contrast-enhanced ultrasound or biopsy will be conducted. The diagnosis of HCC will be made based on international guidelines, with a histological confirmation or classification as Liver Imaging-Reporting and Data System (LI-RADS) category 5. 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. If HCC is confirmed during the study, the participant will be excluded from further study participation, and the treatment will proceed according to current clinical processes. If no lesions are detected during the two surveillance rounds, follow-up for up to 6 months after the second test will be conducted according to current clinical processes. If HCC is diagnosed, which is the primary outcome of the study, the study will be considered complete, and this will not be treated as an adverse event of the study. If a patient chooses not to continue participating in the study during the repeated application of the protocol, the study for that patient will conclude, even if the two rounds of testing are not completed.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- AMRI, CT
- Keywords
- Abbreviated MRI, Dynamic CT
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMRIDiagnostic test
The study subjects will 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 will be conducted using a 3-Tesla 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.
CTDiagnostic test
CT will be performed by obtaining dynamic phases (precontrast phase, arterial phase, portal venous phase, and delayed phase images). Subjects will receive intravenous injection of iodine contrast media. Scan coverage was from the basal lung to the iliac crest or pelvis.
| Study group | Role | What they receive |
|---|---|---|
| AMRI and CT | Experimental | Procedure: AMRI examination The study subjects will 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 will be conducted using a 3-Tesla MRI machine, and the MRI protocol will consist of T2-weighted imaging, diffusion-weighted imaging (b value of 0, 50, and 500 s/mm2), and hepatobiliary phase imaging.
Procedure: dynamic CT CT will be performed by obtaining dynamic phases (precontrast phase, arterial phase, portal venous phase, and delayed phase images). Subjects will receive intravenous injection of iodine contrast media. Scan coverage will be from the basal lung to the iliac crest or pelvis. Receives: Diagnostic Test: AMRI; Diagnostic Test: CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate (DR) of patients with HCC
DR = True positive / True positive + False positive + True negative + False negative
Measured: 6 months after the completion of the 2 surveillance rounds
False referral rate (FRR) of patients with HCC
FRR = False positive / True positive + False positive + True negative + False negative
Measured: 6 months after the completion of the 2 surveillance rounds
Secondary outcomes (4)
DR of patients with early stage HCC
DR = True positive / True positive + False positive + True negative + False negative
Measured: 6 months after the completion of the 2 surveillance rounds
FRR of patients with early stage HCC
FRR = False positive / True positive + False positive + True negative + False negative
Measured: 6 months after the completion of the 2 surveillance rounds
DR of patients with very early stage HCC
DR = True positive / True positive + False positive + True negative + False negative
Measured: 6 months after the completion of the 2 surveillance rounds
FRR of patients with very early stage HCC
FRR = False positive / True positive + False positive + True negative + False negative
Measured: 6 months after the completion of the 2 surveillance rounds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start12 Dec 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2028 (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 Hepatocellular CarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The sample size may be adjusted based on a blinded interim assessment of the pooled event rate.
- Masking
- None (open label)
- Enrolment
- 455 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, So Yeon Kim, Asan Medical Center
- Investigators
- So Yeon Kim, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537193
- Sponsor's protocol ID
- 2023-1630
- Status last verified
- Mar 2026
- First submitted
- 30 Jul 2024
- Last updated
- 10 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park HJ, Lee DH, Chang W, Kim HY, Kim DH, Choi WM, Chung SW, Choi J, Lee D, Shim JH, Lee HC, Lim YS, Kim SO, Singal AG, Kim SY. Multicentre prospective trial of abbreviated MRI using gadoxetic acid versus CT for detection of late recurrent HCC (AMRICT): study protocol. BMJ Open. 2026 Apr 24;16(4):e116809. doi: 10.1136/bmjopen-2026-116809.
PubMed 42031482
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Study for the Intra-Individual Comparison of Abbreviated MRI Using Gadoxetic Acid and Dynamic CT for Surveillance of Recurrent HCC After Curative Treatment
- ClinicalTrials.gov ID
- NCT06537193
- Acronym / sponsor ID
- 2023-1630
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Abbreviated MRI, Dynamic CT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 455 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Aug 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) often has a poor prognosis after curative treatment due to frequent recurrence. Post-surgery, 60-70% of HCC patients experience recurrence, rising to 80% after ablation therapy. This is partly because underlying cirrhosis or chronic liver disease remains, increasing the risk of secondary HCC. The risk of recurrence varies over time, with a high risk in the first two years due to micro-metastasis. Later recurrences are usually new primary cancers (de novo HCC). Therefore, regular imaging tests, such as computed tomography (CT) or magnetic resonance imaging (MRI) every three months in the first two years, are necessary for early detection, but guidelines for post-two-year screenings are unclear.
Currently, for patients recurrence-free for two years, contrast-enhanced liver CT or MRI is performed every 3-6 months as a secondary screening test. However, repeated use of CT raises concerns about radiation exposure and iodine-based contrast agents can lead to side effects and kidney issues. MRI with hepatocyte-specific agents like gadoxetic acid (Primovist) is effective but costly and time-consuming, with potential side effects from repeated gadolinium exposure. Therefore, there is a need for a validated secondary screening method that is both effective and reduces patient risk.
Abbreviated contrast-enhanced MRI, using only essential sequences, has shown promise in retrospective studies for detecting HCC. However, these studies have limitations, such as potential bias and lack of data on repeated screenings. There is limited research on secondary screening post-curative treatment for HCC. This study aims to prospectively evaluate the use of abbreviated contrast-enhanced MRI with Primovist as a secondary screening method for detecting secondary HCC in patients who have been recurrence-free for more than two years.
Detailed description
A total of 455 subjects will be evaluated by two rounds of tests with both abbreviated MRI (AMRI) and dynamic CT to detect the occurrence of secondary HCC. These two imaging tests are planned to be performed twice, with a basic interval of 16 weeks between tests. However, considering the clinical practice of varying the imaging intervals based on the patient's risk level, the actual interval between tests can range from 4 to 8 months. If a suspicious lesion indicative of HCC is detected during the study, a recall examination using complete MRI will be performed within 3 months. If the recall examination does not confirm the diagnosis, a contrast-enhanced ultrasound or biopsy will be conducted. The diagnosis of HCC will be made based on international guidelines, with a histological confirmation or classification as Liver Imaging-Reporting and Data System (LI-RADS) category 5. 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. If HCC is confirmed during the study, the participant will be excluded from further study participation, and the treatment will proceed according to current clinical processes. If no lesions are detected during the two surveillance rounds, follow-up for up to 6 months after the second test will be conducted according to current clinical processes. If HCC is diagnosed, which is the primary outcome of the study, the study will be considered complete, and this will not be treated as an adverse event of the study. If a patient chooses not to continue participating in the study during the repeated application of the protocol, the study for that patient will conclude, even if the two rounds of testing are not completed.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The sample size may be adjusted based on a blinded interim assessment of the pooled event rate.
| Arm | Type | Receives |
|---|---|---|
| AMRI and CT | Experimental | Diagnostic Test: AMRI, Diagnostic Test: CTProcedure: AMRI examination The study subjects will 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 will be conducted using a 3-Tesla MRI machine, and the MRI protocol will consist of T2-weighted imaging, diffusion-weighted imaging (b value of 0, 50, and 500 s/mm2), and hepatobiliary phase imaging. Procedure: dynamic CT CT will be performed by obtaining dynamic phases (precontrast phase, arterial phase, portal venous phase, and delayed phase images). Subjects will receive intravenous injection of iodine contrast media. Scan coverage will be from the basal lung to the iliac crest or pelvis. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with more than two years without recurrence after curative treatment (surgery or local ablation) for HCC
- Patients with no history of systemic treatment, radiation therapy, or trans-arterial chemoembolization for HCC
- Older than 20 years of age
- Eastern Cooperative Oncology Group performance status of 0-2
- Patient is able to comply with scheduled visits, evaluation plans, and other study procedures
Key exclusion criteria (8 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
- Child-Pugh class C
- Patient not eligible for applying LI-RADS criteria, such as Budd-Chiari Syndrome
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 |
|---|---|---|
| AMRIThe study subjects will 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 will be conducted using a 3-Tesla 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. | Diagnostic test | AMRI and CT |
| CTCT will be performed by obtaining dynamic phases (precontrast phase, arterial phase, portal venous phase, and delayed phase images). Subjects will receive intravenous injection of iodine contrast media. Scan coverage was from the basal lung to the iliac crest or pelvis. | Diagnostic test | AMRI and CT |
Primary outcome
Detection rate (DR) of patients with HCC
Time frame: 6 months after the completion of the 2 surveillance rounds
DR = True positive / True positive + False positive + True negative + False negative
False referral rate (FRR) of patients with HCC
Time frame: 6 months after the completion of the 2 surveillance rounds
FRR = False positive / True positive + False positive + True negative + False negative
4 secondary outcomes
DR of patients with early stage HCC
Time frame: 6 months after the completion of the 2 surveillance rounds
FRR of patients with early stage HCC
Time frame: 6 months after the completion of the 2 surveillance rounds
DR of patients with very early stage HCC
Time frame: 6 months after the completion of the 2 surveillance rounds
FRR of patients with very early stage HCC
Time frame: 6 months after the completion of the 2 surveillance rounds
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 10 Mar 2026.
- Derived from this study: PubMed 42031482Park HJ, Lee DH, Chang W, Kim HY, Kim DH, Choi WM, Chung SW, Choi J, Lee D, Shim JH, Lee HC, Lim YS, Kim SO, Singal AG, Kim SY. Multicentre prospective trial of abbreviated MRI using gadoxetic acid versus CT for detection of late recurrent HCC (AMRICT): study protocol. BMJ Open. 2026 Apr 24;16(4):e116809. doi: 10.1136/bmjopen-2026-116809.
- 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.
So Yeon Kim, MD, PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMRI and CT in people with 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 10 Mar 2026. 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?
Contact So Yeon Kim, MD, PhD (82-2-3010-6575, sykim.radiology@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate (DR) of patients with HCC (time frame: 6 months after the completion of the 2 surveillance rounds). The study lists 2 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 NCT06537193, 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 10 Mar 2026.