Annual MRI Versus Biannual US for Surveillance of Hepatocellular Carcinoma in Liver Cirrhosis

Liver Cirrhosis Clinical Trial

— MAGNUS-HCC  

Official title:

Comparison of Biannual Ultrasonography and Annual Unenhanced Magnetic Resonance Imaging as a Surveillance Test for Hepatocellular Carcinoma in Patients With Liver Cirrhosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02551250
• Other study ID #: 1520160
• Status: Active, not recruiting
• Start date: September 2015
• Est. completion date: December 2019

Study information

• Verified date: September 2019
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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 (US) 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 alpha feto protein(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 and limited availability. 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 trial, the investigators will investigate the usefulness of biannual ultrasonography versus annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 211
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 99 Years

Eligibility

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-feeding

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Fibrosis
• Liver Cirrhosis

Intervention

Device:
• annual noncontrast MRI
liver MRI without contrast agents T2 weighted image, T1 in/out of phase, diffusion weighted images with b-values of 0, 500 mm2/s
• biannual ultrasonography
liver ultrasonography for HCC screening performed by experienced sonologists

Locations

Country	Name	City	State
Korea, Republic of	Korean University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St.Mary's Hospital	Seoul
Korea, Republic of	St.Vincent's Hospital	Suwon
Korea, Republic of	Uijeongbu St.Mary's Hospital	Uijeongbu

Sponsors (6)

Lead Sponsor	Collaborator
JOON-IL CHOI	Korea University Guro Hospital, National Cancer Center, Korea, Samsung Medical Center, Seoul National University Hospital, The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Kim 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity for detecting HCC	sensitivity for detecting HCC	3 years
Secondary	survival of the patients who developed HCC on follow-up period	survival of the patients who developed HCC on follow-up period	years
Secondary	false referral rate for HCC	false referral rate for HCC	3 years