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

NCT02551250 | Completed

• 1 other identifier: 1520160
• Study Type: observational
• Target: 211
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Liver Cirrhosis

Keywords

hepatocellular carcinoma; surveillance; liver cirrhosis; ultrasonography; magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• sensitivity for detecting HCC

  sensitivity for detecting HCC

  3 years

Secondary Outcomes (2)

• survival of the patients who developed HCC on follow-up period

  years

• false referral rate for HCC

  3 years

Study Arms (1)

Study

Surveillance of HCC by biannual ultrasonography AND annual noncontrast MRI

Device: annual noncontrast MRI; Device: biannual ultrasonography

Interventions

annual noncontrast MRI DEVICE

liver MRI without contrast agents T2 weighted image, T1 in/out of phase, diffusion weighted images with b-values of 0, 500 mm2/s

Study

biannual ultrasonography DEVICE

liver ultrasonography for HCC screening performed by experienced sonologists

Study

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with the risk of annual HCC occurrence larger than 5%

You may qualify if:

• 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
• Histologically by liver biopsy;
• 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).

You may not qualify if:

• Presence of liver cancer or other intrahepatic malignancy
• Has a history of malignancy within previous 5 years
• Is pregnant or breast-feeding

Sponsors & Collaborators

• JOON-IL CHOI: lead
• Seoul National University Hospital: collaborator
• Samsung Medical Center: collaborator
• Korea University Guro Hospital: collaborator
• The Catholic University of Korea: collaborator
• National Cancer Center, Korea: collaborator

Study Sites (6)

Seoul St.Mary's Hospital

Seoul, 06591, South Korea

Location

Korean University Guro Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

St.Vincent's Hospital

Suwon, South Korea

Location

Uijeongbu St.Mary's Hospital

Uijeongbu-si, South Korea

Location

Related Publications (3)

• 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. doi: 10.1016/j.mri.2013.12.021. Epub 2014 Jan 13.

  PMID: 24702980 RESULT

• Kim DH, Yoon JH, Choi MH, Lee CH, Kang TW, Kim HA, Ku YM, Lee JM, Kim SH, Kim KA, Lee SL, Choi JI. Comparison of non-contrast abbreviated MRI and ultrasound as surveillance modalities for HCC. J Hepatol. 2024 Sep;81(3):461-470. doi: 10.1016/j.jhep.2024.03.048. Epub 2024 Apr 16.

  PMID: 38636849 DERIVED

• Kim HA, Kim KA, Choi JI, Lee JM, Lee CH, Kang TW, Ku YM, Lee SL, Park YS, Yoon JH, Kim SH, Choi MH. Comparison of biannual ultrasonography and annual non-contrast liver magnetic resonance imaging as surveillance tools for hepatocellular carcinoma in patients with liver cirrhosis (MAGNUS-HCC): a study protocol. BMC Cancer. 2017 Dec 21;17(1):877. doi: 10.1186/s12885-017-3819-y.

  PMID: 29268722 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Study Officials

• Joon-Il Choi

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: September 16, 2015
• Study Start: September 1, 2015
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: April 23, 2026

Record last verified: 2019-09

Locations

KR (6)