Usefulness of Non-contrast MagnetIc Resonance imAging Versus Non-Contrast Ultrasonography for surveiLlancE of HepatoCellular Carcinoma [MIRACLE-HCC]

Yonsei University

Status: Unknown

Conditions: Compensated Liver Cirrhosis

Treatments: Radiation: non-contrast MRI; Radiation: Ultrasonography

Study type: Interventional

Funder types: Other

Identifiers

NCT02514434

4-2015-0029

Details and patient eligibility

About

The investigators will investigate the usefulness of ultrasonography versus non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma through this prospective, randomized trial.

Full 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.

Enrollment: 416 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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416 participants in 2 patient groups

Ultrasonography

Experimental group

Description:

Subjects will be regularly screened for HCC by ultrasonography with serum AFP(alpha fetoprotein).

Treatment:

Radiation: Ultrasonography

Non-contrast MRI

Experimental group

Description:

Subjects will be regularly screened for HCC by non-contrast magnetic resonance imaging(MRI) with serum AFP(alpha fetoprotein).

Treatment:

Radiation: non-contrast MRI