Added Value of Gadoxetic Acid-enhanced Liver MRI

Seoul National University Hospital130 enrolled

Overview

It would be valuable to evaluate whether gadoxetic acid-enhanced liver MRI would provide additional value for characterizing atypical or small (1\~2cm) hepatic nodules at CT and to reduce the necessity of biopsy in patients with high risk of HCC. Therefore, the purpose of this study is to evaluate added value of gadoxetic acid-enhanced MRI for diagnosis of HCC in patients with small (10-19mm) or atypical hepatic nodules at CT.

In terms of confirmative diagnosis, HCC is unique compared with other malignant tumors, as it can be diagnosed noninvasively based on its characteristic imaging features, that is, arterial hyperenhancement (washin) and hypoenhancement (washout) on portal or delayed phase at contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) using extracellular contrast media (ECCM). According to Liver Imaging Reporting and Data System (LI-RADS), hypointensity and isointensity on hepatobiliary phase (HBP) at gadoxetic acid-enhanced MRI are suggestive of malignancy and benignity, respectively, and those features are uniquely provided by only hepatocyte-specific contrast agent. However, these features are not included in diagnostic criteria because of its non-specificity, and indeed, gadoxetic acid-enhanced MRI is not yet included in AASLD and EASL guidelines as a diagnostic modality. If gadoxetic acid-enhanced MRI would provide better performance to diagnose HCC than CT, gadoxetic acid-enhanced MRI should be considered as a next step before biopsy in those small and/or atypical nodules to avoid potential diagnostic pitfall and morbidity, which is currently depending on physicians' decision. Thus, it would be valuable to evaluate whether gadoxetic acid-enhanced liver MRI would provide additional value for characterizing atypical or small (1\~2cm) hepatic nodules at CT and to reduce the necessity of biopsy in patients with high risk of HCC. Therefore, the purpose of this study is to evaluate added value of gadoxetic acid-enhanced MRI for diagnosis of HCC in patients with small (10-19mm) or atypical hepatic nodules at CT.

Study Type

OBSERVATIONAL

Enrollment

130

Conditions

Hcc Diagnosis

Interventions

gadoxetic acid-enhanced liver MRIPROCEDURE

liver MRI using a standard dose (0.025mmol/kg) of gadoxetic acid

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients with chronic hepatitis B or cirrhosis of any etiology * signed informed consent AND * being referred to radiology department for gadoxetic acid-enhanced MRI due to small nodule (10-19mm) at contrast-enhanced CT scan within 30 days as an radiofrequency ablation (RFA) work-up OR * being referred to radiology department for percutaneous biopsy for atypical hepatic nodules (≥20mm) detected at contrast-enhanced CT within 30 days before biopsy Exclusion Criteria: * Any contraindication for MRI and MR contrast agent

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

sensitivity to diagnose HCC, per-nodule base

sensitivity of HCC on CT and gadoxetic acid MRI, per-nodule base

Time frame: 12 months after MRI

Secondary Outcomes

specificity to diagnose HCC, per-nodule base

specificity of HCC on CT and gadoxetic acid MRI, per-nodule base

Time frame: 12 months after MRI

sensitivity to diagnose HCC, per-patient base

sensitivity of HCC on CT and gadoxetic acid MRI, per-patient base

Time frame: 12 months after MRI

specificity to diagnose HCC, per-patient base

specificity of HCC on CT and gadoxetic acid MRI, per-patient base

Time frame: 12 months after MRI

Data from ClinicalTrials.gov

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