Compensated Liver CirrhosisNCT02514434
Usefulness of Non-contrast MagnetIc Resonance imAging Versus Non-Contrast Ultrasonography for surveiLlancE of HepatoCellular Carcinoma [MIRACLE-HCC]
A study testing Ultrasonography and non-contrast MRI in people with Compensated Liver Cirrhosis, run by Yonsei University at 1 site in South Korea.
Trial summary
The investigators will investigate the usefulness of ultrasonography versus non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma through this prospective, randomized trial. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Compensated Liver Cirrhosis
- What is being tested?
- Ultrasonography and non-contrast MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Mar 2015to Dec 2022
- Phase
- Interventional
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Institute of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine
Seoul, 120-752
About this study
The investigators will investigate the usefulness of ultrasonography versus non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma through this prospective, randomized trial.
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 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 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. 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, randomized trial, the investigators will investigate the usefulness of ultrasonography versus non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma.
- Conditions
- Compensated Liver Cirrhosis
- Being tested
- Ultrasonography, non-contrast MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyRadiation
Subjects will be randomly allocated to either Ultrasonography arm or Non-contrast MRI arm for their surveillance method.
non-contrast MRIRadiation
Subjects will be randomly allocated to either Ultrasonography arm or Non-contrast MRI arm for their surveillance method.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonography | Experimental | Subjects will be regularly screened for HCC by ultrasonography with serum AFP(alpha fetoprotein). Receives: Radiation: Ultrasonography |
| Non-contrast MRI | Experimental | Subjects will be regularly screened for HCC by non-contrast magnetic resonance imaging(MRI) with serum AFP(alpha fetoprotein). Receives: Radiation: non-contrast MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor stage of HCC
Comparing tumor stage and resectability rate of HCC between participants undergoing HCC surveillance using ultrasonography and non-contrast MRI.
Measured: 6 months
Resectability rate of HCC
Comparing tumor stage and resectability rate of HCC between participants undergoing HCC surveillance using ultrasonography and non-contrast MRI.
Measured: 6 months
Secondary outcomes (3)
Five-year overall survival
Measured: 5 years after the study enrollment
Liver-related mortality
Measured: 5 years after the study enrollment
Post-treatment recurrence rate
Measured: 5 years after the study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study start30 Mar 2015
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Compensated Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- 416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514434
- Sponsor's protocol ID
- 4-2015-0029
- Status last verified
- Mar 2019
- First submitted
- 23 Jul 2015
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Rhee 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.
PubMed 39855314An 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.
PubMed 30249190
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Non-contrast MagnetIc Resonance imAging Versus Non-Contrast Ultrasonography for surveiLlancE of HepatoCellular Carcinoma [MIRACLE-HCC]
- ClinicalTrials.gov ID
- NCT02514434
- Acronym / sponsor ID
- 4-2015-0029
- Conditions
- Compensated Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 30 Mar 2015 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 3 Aug 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 ultrasonography versus non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma through this prospective, randomized trial.
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 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 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. 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, randomized trial, the investigators will investigate the usefulness of ultrasonography versus non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasonography | Experimental | Radiation: UltrasonographySubjects will be regularly screened for HCC by ultrasonography with serum AFP(alpha fetoprotein). |
| Non-contrast MRI | Experimental | Radiation: non-contrast MRISubjects will be regularly screened for HCC by non-contrast magnetic resonance imaging(MRI) with serum AFP(alpha fetoprotein). |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| UltrasonographySubjects will be randomly allocated to either Ultrasonography arm or Non-contrast MRI arm for their surveillance method. | Radiation | Ultrasonography |
| non-contrast MRISubjects will be randomly allocated to either Ultrasonography arm or Non-contrast MRI arm for their surveillance method. | Radiation | Non-contrast MRI |
Primary outcome
Tumor stage of HCC
Time frame: 6 months
Comparing tumor stage and resectability rate of HCC between participants undergoing HCC surveillance using ultrasonography and non-contrast MRI.
Resectability rate of HCC
Time frame: 6 months
Comparing tumor stage and resectability rate of HCC between participants undergoing HCC surveillance using ultrasonography and non-contrast MRI.
3 secondary outcomes
Five-year overall survival
Time frame: 5 years after the study enrollment
Liver-related mortality
Time frame: 5 years after the study enrollment
Post-treatment recurrence rate
Time frame: 5 years after the study enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Derived from this study: PubMed 39855314Rhee 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.
- Derived from this study: PubMed 30249190An 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.
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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 Ultrasonography and non-contrast MRI in people with Compensated Liver Cirrhosis, run by Yonsei University 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 4 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: status not confirmed, as of the sponsor's last update on 21 Mar 2019. 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?
Results are not available in the source record.
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?
Tumor stage of HCC (time frame: 6 months). 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 NCT02514434, which also lists 2 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 21 Mar 2019.