Added Value of Gadoxetic Acid-enhanced Liver MRI

Completed

• Conditions: Diagnosis; Hcc
• Interventions: Procedure: gadoxetic acid-enhanced liver MRI

• Registration Number: NCT03045419
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2009-12-29
• Primary Completion: 2013-11-24
• Study Completion: 2016-12-31
• Status Verified: 2017-02
• Study First Submitted: 2017-02-03
• Study First Submitted QC: 2017-02-03
• Last Update Submitted: 2017-02-03
• Study First Posted: 2017-02-07
• Last Update Posted: 2017-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients group	gadoxetic acid-enhanced liver MRI	* with small hepatic nodules (10-19mm) or atypical hepatic nodule (= or \> 20mm) and high-risk group of HCC * scheduled for gadoxetic acid-enhanced liver MRI or liver nodule biopsy
Living liver donor candidates	gadoxetic acid-enhanced liver MRI	* living liver donor candidates without history of liver disease * schedule for gadoxetic acid-enhanced liver MRI as preoperative workup * only used for control of normal liver parenchymal enhancement on hepatobiliary phase

Primary Outcome Measures

Name	Time	Method
sensitivity to diagnose HCC, per-nodule base	12 months after MRI	sensitivity of HCC on CT and gadoxetic acid MRI, per-nodule base

Secondary Outcome Measures

Name	Time	Method
specificity to diagnose HCC, per-nodule base	12 months after MRI	specificity of HCC on CT and gadoxetic acid MRI, per-nodule base
sensitivity to diagnose HCC, per-patient base	12 months after MRI	sensitivity of HCC on CT and gadoxetic acid MRI, per-patient base
specificity to diagnose HCC, per-patient base	12 months after MRI	specificity of HCC on CT and gadoxetic acid MRI, per-patient base

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of