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The investigators will investigate the usefulness of ultrasonography versus non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma through this prospective, randomized trial.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasonography | Experimental | Subjects will be regularly screened for HCC by ultrasonography with serum AFP(alpha fetoprotein). |
|
| Non-contrast MRI | Experimental | Subjects will be regularly screened for HCC by non-contrast magnetic resonance imaging(MRI) with serum AFP(alpha fetoprotein). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasonography | Radiation | Subjects will be randomly allocated to either Ultrasonography arm or Non-contrast MRI arm for their surveillance method. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor stage of HCC | Comparing tumor stage and resectability rate of HCC between participants undergoing HCC surveillance using ultrasonography and non-contrast MRI. | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Five-year overall survival | 5 years after the study enrollment | |
| Liver-related mortality | 5 years after the study enrollment | |
| Post-treatment recurrence rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine | Seoul | 120-752 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39855314 | Derived | 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. | |
| 30249190 |
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| non-contrast MRI | Radiation | Subjects will be randomly allocated to either Ultrasonography arm or Non-contrast MRI arm for their surveillance method. |
|
| 5 years after the study enrollment |
| Derived |
| An 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. |
| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
| D055585 | Physical Phenomena |
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