Clinical trial · Observational
Annual MRI Versus Biannual US for Surveillance of Hepatocellular Carcinoma in Liver Cirrhosis
Comparison of Biannual Ultrasonography and Annual Unenhanced Magnetic Resonance Imaging as a Surveillance Test for Hepatocellular Carcinoma in Patients With Liver Cirrhosis
NCT02551250CI-TRIAL-00109305MAGNUS-HCCcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cirrhosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| annual noncontrast MRI | Device | — | UNRESOLVED |
| biannual ultrasonography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Study
- description
- Surveillance of HCC by biannual ultrasonography AND annual noncontrast MRI
- interventionNames
- Device: annual noncontrast MRI
- Device: biannual ultrasonography
Primary outcomes (1)
- measure
- sensitivity for detecting HCC
- timeFrame
- 3 years
- description
- sensitivity for detecting HCC
Secondary outcomes (2)
- measure
- survival of the patients who developed HCC on follow-up period
- timeFrame
- years
- description
- survival of the patients who developed HCC on follow-up period
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria:
* Male or female subject older than 40 years of age at the enrollment
* Fulfill below conditions A and B
A. The evidence of cirrhosis of any etiology within 12 months prior to screening Definition of cirrhosis by any of following methods
1. Histologically by liver biopsy;
2. Non-histologically by evidence of portal hypertension in the presence of chronic liver disease;
* Evidence of portal hypertension, including any of followings;
* 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
B. 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).
Exclusion Criteria:
* Presence of liver cancer or other intrahepatic malignancy
* Has a history of malignancy within previous 5 years
* Is pregnant or breast-feedingReferences
Publications (3)
- RESULTKim 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. PMID 24702980
- DERIVEDKim 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. PMID 38636849
- DERIVEDKim 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. PMID 29268722