Added Value of Gadoxetic Acid-enhanced Liver MRI

Seoul National University

Status: Completed

Conditions: Diagnosis; Hcc

Treatments: Procedure: gadoxetic acid-enhanced liver MRI

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03045419

SNUH-2009-5441

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

130 participants in 2 patient groups

Patients group

Description:

* 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

Treatment:

Procedure: gadoxetic acid-enhanced liver MRI

Living liver donor candidates

Description:

* 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

Treatment:

Procedure: gadoxetic acid-enhanced liver MRI