Liver CirrhosisMAGNUS-HCCNCT02551250
Annual MRI Versus Biannual US for Surveillance of Hepatocellular Carcinoma in Liver Cirrhosis
An observational study of Liver Cirrhosis, run by JOON-IL CHOI at 6 sites in South Korea.
Trial summary
The investigators will investigate the usefulness of biannual ultrasonography versus annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma in single arm patients. Read more about this study
- Who is it for?
- Ages 40 to 99 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- annual noncontrast MRI and biannual ultrasonography
- Type of treatment
- Medical device
- How many people
- 211 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 1 Sep 2015to 31 Dec 2020
- How long will I take part?
- 3 Years
- 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 40 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with the risk of annual HCC occurrence larger than 5%
Who may be able to join
- Male or female subject older than 40 years of age at the enrollment
- Fulfill below conditions A and B
- The evidence of cirrhosis of any etiology within 12 months prior to screening Definition of cirrhosis by any of following methods
- Histologically by liver biopsy;
- Non-histologically by evidence of portal hypertension in the presence of chronic liver disease;
- Evidence of portal hypertension, including any of followings;
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- The identification of splenomegaly on ultrasonography, CT, or MRI examinations with typical features of cirrhosis
- The identification of esophageal or gastric varices on endoscopic examination
- Risk Index larger than 2.33; 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 <=100,000/mm3) + 0.74 (if the presence of HCV is positive).
Who cannot join
- Presence of liver cancer or other intrahepatic malignancy
- Has a history of malignancy within previous 5 years
- Is pregnant or breast-feeding
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Seoul St.Mary's Hospital
Seoul, 06591
Korean University Guro Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
St.Vincent's Hospital
Suwon
Uijeongbu St.Mary's Hospital
Uijeongbu-si
About this study
Official title: Comparison of Biannual Ultrasonography and Annual Unenhanced Magnetic Resonance Imaging as a Surveillance Test for Hepatocellular Carcinoma in Patients With Liver Cirrhosis
The investigators will investigate the usefulness of biannual ultrasonography versus annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma in single arm patients.
Read the detailed description
Hepatocellular carcinoma (HCC) is one of the major complications in patients with chronic liver disease. The prognosis of HCC relies on the extent of disease at the time of diagnosis. Hence to detect cancer at an earlier stage, a regular surveillance test is important for the subjects with a high risk of developing cancer. Current guidelines recommend a regular surveillance using ultrasonography (US) at a 6 month-interval. Ultrasonography is a non-invasive and safe procedure, yet it is limited by the skills of the operator and it is often difficult to differentiate cancer from regenerating nodules especially in atrophied cirrhotic liver. According to a recent meta-analysis, the overall sensitivity and specificity of detecting liver cancer using ultrasonography were both over 90%, however the sensitivity was decreased to 60% in detecting early lesions in which surgery or liver transplantation is indicated. Of note, addition of alpha feto protein(AFP) to ultrasonography also failed to increase the sensitivity in detecting small cancers. Taken together, there is a need to develop a new surveillance test with an improved sensitivity and specificity.
Recently, a retrospective study reported that CT or MRI showed a better sensitivity than ultrasonography in detecting early liver cancer. However, performing CT as a surveillance test is limited by frequent exposure to radiation and contrast-dye agent. Although MRI does not have the risk of radiation-exposure, it is limited by the high cost and limited availability. On the contrast, non-contrast MRI offers a cost that is comparable to US and an absence of exposure to radiation or contrast-dye agent, which suggests non-contrast MRI as a good alternative surveillance tool for early detection of HCC. Therefore, in this prospective trial, the investigators will investigate the usefulness of biannual ultrasonography versus annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma.
- Conditions
- Liver Cirrhosis
- Being tested
- annual noncontrast MRI, biannual ultrasonography
- Keywords
- hepatocellular carcinoma, surveillance, liver cirrhosis, ultrasonography, magnetic resonance imaging
- 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.
annual noncontrast MRIDevice
liver MRI without contrast agents T2 weighted image, T1 in/out of phase, diffusion weighted images with b-values of 0, 500 mm2/s
biannual ultrasonographyDevice
liver ultrasonography for HCC screening performed by experienced sonologists
| Study group | Role | What they receive |
|---|---|---|
| Study | Surveillance of HCC by biannual ultrasonography AND annual noncontrast MRI Receives: Device: annual noncontrast MRI; Device: biannual ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity for detecting HCC
sensitivity for detecting HCC
Measured: 3 years
Secondary outcomes (2)
survival of the patients who developed HCC on follow-up period
survival of the patients who developed HCC on follow-up period
Measured: years
false referral rate for HCC
false referral rate for HCC
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study start1 Sep 2015
- Primary completion31 Dec 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 211 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- JOON-IL CHOI
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Hospital, Samsung Medical Center, Korea University Guro Hospital, The Catholic University of Korea, National Cancer Center, Korea
- Responsible party
- Sponsor-investigator, JOON-IL CHOI, Seoul St. Mary's Hospital
- Investigators
- Joon-Il Choi, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551250
- Sponsor's protocol ID
- 1520160
- Acronym
- MAGNUS-HCC
- Status last verified
- Sep 2019
- First submitted
- 15 Sep 2015
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Kim YK, Kim YK, Park HJ, Park MJ, Lee WJ, Choi D. Noncontrast MRI with diffusion-weighted imaging as the sole imaging modality for detecting liver malignancy in patients with high risk for hepatocellular carcinoma. Magn Reson Imaging. 2014 Jul;32(6):610-8. doi: 10.1016/j.mri.2013.12.021. Epub 2014 Jan 13.
PubMed 24702980Kim DH, Yoon JH, Choi MH, Lee CH, Kang TW, Kim HA, Ku YM, Lee JM, Kim SH, Kim KA, Lee SL, Choi JI. Comparison of non-contrast abbreviated MRI and ultrasound as surveillance modalities for HCC. J Hepatol. 2024 Sep;81(3):461-470. doi: 10.1016/j.jhep.2024.03.048. Epub 2024 Apr 16.
PubMed 38636849Kim HA, Kim KA, Choi JI, Lee JM, Lee CH, Kang TW, Ku YM, Lee SL, Park YS, Yoon JH, Kim SH, Choi MH. Comparison of biannual ultrasonography and annual non-contrast liver magnetic resonance imaging as surveillance tools for hepatocellular carcinoma in patients with liver cirrhosis (MAGNUS-HCC): a study protocol. BMC Cancer. 2017 Dec 21;17(1):877. doi: 10.1186/s12885-017-3819-y.
PubMed 29268722
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Biannual Ultrasonography and Annual Unenhanced Magnetic Resonance Imaging as a Surveillance Test for Hepatocellular Carcinoma in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT02551250
- Acronym / sponsor ID
- MAGNUS-HCC / 1520160
- Conditions
- Liver Cirrhosis
- Keywords
- hepatocellular carcinoma, surveillance, liver cirrhosis, ultrasonography, magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- JOON-IL CHOIUniversity, hospital or other
- Collaborators
- Seoul National University Hospital, Samsung Medical Center, Korea University Guro Hospital, The Catholic University of Korea, National Cancer Center, Korea
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 16 Sep 2015 (estimated)
- 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.
The investigators will investigate the usefulness of biannual ultrasonography versus annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma in single arm patients.
Detailed description
Hepatocellular carcinoma (HCC) is one of the major complications in patients with chronic liver disease. The prognosis of HCC relies on the extent of disease at the time of diagnosis. Hence to detect cancer at an earlier stage, a regular surveillance test is important for the subjects with a high risk of developing cancer. Current guidelines recommend a regular surveillance using ultrasonography (US) at a 6 month-interval. Ultrasonography is a non-invasive and safe procedure, yet it is limited by the skills of the operator and it is often difficult to differentiate cancer from regenerating nodules especially in atrophied cirrhotic liver. According to a recent meta-analysis, the overall sensitivity and specificity of detecting liver cancer using ultrasonography were both over 90%, however the sensitivity was decreased to 60% in detecting early lesions in which surgery or liver transplantation is indicated. Of note, addition of alpha feto protein(AFP) to ultrasonography also failed to increase the sensitivity in detecting small cancers. Taken together, there is a need to develop a new surveillance test with an improved sensitivity and specificity.
Recently, a retrospective study reported that CT or MRI showed a better sensitivity than ultrasonography in detecting early liver cancer. However, performing CT as a surveillance test is limited by frequent exposure to radiation and contrast-dye agent. Although MRI does not have the risk of radiation-exposure, it is limited by the high cost and limited availability. On the contrast, non-contrast MRI offers a cost that is comparable to US and an absence of exposure to radiation or contrast-dye agent, which suggests non-contrast MRI as a good alternative surveillance tool for early detection of HCC. Therefore, in this prospective trial, the investigators will investigate the usefulness of biannual ultrasonography versus annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study | – | Device: annual noncontrast MRI, Device: biannual ultrasonographySurveillance of HCC by biannual ultrasonography AND annual noncontrast MRI |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with the risk of annual HCC occurrence larger than 5%
Key inclusion criteria (9 listed)
- Male or female subject older than 40 years of age at the enrollment
- Fulfill below conditions A and B
- The evidence of cirrhosis of any etiology within 12 months prior to screening Definition of cirrhosis by any of following methods
- Histologically by liver biopsy;
- Non-histologically by evidence of portal hypertension in the presence of chronic liver disease;
Key exclusion criteria (3 listed)
- Presence of liver cancer or other intrahepatic malignancy
- Has a history of malignancy within previous 5 years
- Is pregnant or breast-feeding
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 |
|---|---|---|
| annual noncontrast MRIliver MRI without contrast agents T2 weighted image, T1 in/out of phase, diffusion weighted images with b-values of 0, 500 mm2/s | Device | Study |
| biannual ultrasonographyliver ultrasonography for HCC screening performed by experienced sonologists | Device | Study |
Primary outcome
sensitivity for detecting HCC
Time frame: 3 years
sensitivity for detecting HCC
2 secondary outcomes
survival of the patients who developed HCC on follow-up period
Time frame: years
false referral rate for HCC
Time frame: 3 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 23 Apr 2026.
- Results publication: PubMed 24702980Kim YK, Kim YK, Park HJ, Park MJ, Lee WJ, Choi D. Noncontrast MRI with diffusion-weighted imaging as the sole imaging modality for detecting liver malignancy in patients with high risk for hepatocellular carcinoma. Magn Reson Imaging. 2014 Jul;32(6):610-8. doi: 10.1016/j.mri.2013.12.021. Epub 2014 Jan 13.
- Derived from this study: PubMed 38636849Kim DH, Yoon JH, Choi MH, Lee CH, Kang TW, Kim HA, Ku YM, Lee JM, Kim SH, Kim KA, Lee SL, Choi JI. Comparison of non-contrast abbreviated MRI and ultrasound as surveillance modalities for HCC. J Hepatol. 2024 Sep;81(3):461-470. doi: 10.1016/j.jhep.2024.03.048. Epub 2024 Apr 16.
- Derived from this study: PubMed 29268722Kim HA, Kim KA, Choi JI, Lee JM, Lee CH, Kang TW, Ku YM, Lee SL, Park YS, Yoon JH, Kim SH, Choi MH. Comparison of biannual ultrasonography and annual non-contrast liver magnetic resonance imaging as surveillance tools for hepatocellular carcinoma in patients with liver cirrhosis (MAGNUS-HCC): a study protocol. BMC Cancer. 2017 Dec 21;17(1):877. doi: 10.1186/s12885-017-3819-y.
- Individual participant dataSharing planned: Undecided
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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.
Joon-Il Choi principal investigator
Seoul St. Mary's Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by JOON-IL CHOI at 6 sites 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 9 inclusion and 3 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 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
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 for detecting HCC (time frame: 3 years). 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 NCT02551250, which also lists 3 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 23 Apr 2026.