protocolSection identificationModule nctId: NCT06312826, orgStudyIdInfo id: KCT0007417, secondaryIdInfos id: 2022-0661, type: OTHER, domain: Asan Medical Center Institutional Review Board, briefTitle: Abbreviated MRI Using Gadoxetic Acid Versus Ultrasonography for Surveillance of Early-stage HCC in Patients at High Risk, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-08-26, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: So Yeon Kim, class: OTHER, descriptionModule briefSummary: Hepatocellular carcinoma (HCC) is the third most frequent cause of cancer-related deaths worldwide. The incidence of HCC has been rapidly rising worldwide over the last two decades. In order to improve survival with curative treatment, regular surveillance to detect early-stage HCC is recommended for at-risk populations. Although ultrasonography (US) has been endorsed as the primary surveillance tool for HCC, a recent meta-analysis found that US has a sensitivity of 47% for detecting early-stage HCC, and its sensitivity for detecting early-stage HCC has been questioned. Many recent studies have explored the potential of alternative surveillance tools for HCC other than US, particularly for high-risk patients. Although complete gadoxetic acid-enhanced magnetic resonance imaging (MRI) demonstrated excellent performance, its high cost and long examination time can hamper its widespread adoption. Abbreviated MRI (AMRI) including hepatobiliary-phase imaging is a promising option to detect potential indicators of HCC, maintaining the benefits of highly sensitive imaging while reducing the examination time by omitting dynamic contrast-enhanced imaging. Because US is the current primary surveillance tool for HCC, this new surveillance tool must be compared with US in a prospective randomized comparative design.Thus, the hypothesis to be proved in this study is as follows: AMRI with gadoxetic acid will show a significantly higher detection rate compared to US for the detection of early-stage HCC in patients with cirrhosis and at high risk of developing HCC, defined as an estimated annual HCC risk of higher than 5%. We will also analyze whether the false-referral rate of AMRI with gadoxetic acid is not compromised by its high detection rate., conditionsModule conditions: Liver Cirrhosis, conditions: Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 806, type: ESTIMATED, armsInterventionsModule interventions name: Abdominal US, interventions name: AMRI, outcomesModule primaryOutcomes measure: Detection rate of patients with early stage HCC, secondaryOutcomes measure: Detection rate of patients with very early stage HCC, secondaryOutcomes measure: False referral rate of patients with early stage HCC, secondaryOutcomes measure: False referral rate of patients with very early stage HCC, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Asan Medical Center, status: RECRUITING, city: Seoul, state: Songpa-gu, zip: 05505, country: Korea, Republic of, contacts name: So Yeon Kim, MD, PhD, role: CONTACT, phone: 82-2-3010-7166, email: sykim.radiology@gmail.com, contacts name: Hyo Jung Park, MD, PhD, role: CONTACT, phone: 82-2-3010-7166, email: happyeahj@gmail.com, contacts name: Jonggi Choi, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 37.566, lon: 126.9784, locations facility: Asan Medical Center, status: RECRUITING, city: Seoul, state: Songpa-gu, zip: 05505, country: Korea, Republic of, contacts name: So Yeon Kim, MD, PhD, role: CONTACT, phone: 82-2-3010-6575, email: sykim.radiology@gmail.com, contacts name: Hyo Jung Park, MD, PhD, role: CONTACT, phone: 82-2-3010-6575, email: happyeahj@gmail.com, contacts name: Jonggi Choi, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 37.566, lon: 126.9784, hasResults: False