Clinical trial · Interventional
Usefulness of Non-contrast MagnetIc Resonance imAging Versus Non-Contrast Ultrasonography for surveiLlancE of HepatoCellular Carcinoma [MIRACLE-HCC]
NCT02514434CI-TRIAL-00037736unknownN/AClinicalTrials.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 ultrasonography versus non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma through this prospective, randomized trial.
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 |
|---|---|---|---|
| Compensated Liver Cirrhosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| non-contrast MRI | Radiation | — | UNRESOLVED |
| Ultrasonography | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ultrasonography
- description
- Subjects will be regularly screened for HCC by ultrasonography with serum AFP(alpha fetoprotein).
- interventionNames
- Radiation: Ultrasonography
- type
- EXPERIMENTAL
- label
- Non-contrast MRI
- description
- Subjects will be regularly screened for HCC by non-contrast magnetic resonance imaging(MRI) with serum AFP(alpha fetoprotein).
- interventionNames
- Radiation: non-contrast MRI
Primary outcomes (2)
- measure
- Tumor stage of HCC
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female subject between 20 and 70 years of age at the time of randomization * Has chronic liver disease with compensated liver cirrhosis (Child-Pugh score A), defined as 1) histologically confirmed cirrhosis, or 2) has chronic liver disease and shows the presence of splenomegaly or other typical findings of liver cirrhosis on ultrasonography, computed tomography, or magnetic resonance imaging, or 3) has chronic liver disease and shows the presence of endoscopically-confirmed esophageal or gastric varices * Absence of severe cardiovascular, pulmonary, renal or infectious diseases, other than chronic liver disease * Absence of a history of malignancy within previous 5 years * Can and will comply with the requirements of the protocol (e.g. return for follow-up visits), in the opinion of the investigator * Has provided written informed consent Exclusion Criteria: * Greater than 70 years of age * Presence of liver cancer or other intrahepatic malignancy * Has a history of malignancy within previous 5 years * Is pregnant or breast-feeding
References
Publications (2)
- DERIVEDRhee H, Kim MJ, Kim DY, An C, Kang W, Han K, Roh YH, Han KH, Ahn SH, Choi JY, Park JY, Chung YE, Kim SU, Kim BK, Lee S, Lee HW, Lee JS. Noncontrast Magnetic Resonance Imaging vs Ultrasonography for Hepatocellular Carcinoma Surveillance: A Randomized, Single-Center Trial. Gastroenterology. 2025 Jun;168(6):1170-1177.e12. doi: 10.1053/j.gastro.2024.12.035. Epub 2025 Jan 22. PMID 39855314
- DERIVEDAn C, Kim DY, Choi JY, Han KH, Roh YH, Kim MJ. Noncontrast magnetic resonance imaging versus ultrasonography for hepatocellular carcinoma surveillance (MIRACLE-HCC): study protocol for a prospective randomized trial. BMC Cancer. 2018 Sep 24;18(1):915. doi: 10.1186/s12885-018-4827-2. PMID 30249190