Added Value of Gadoxetic Acid-enhanced Liver MRI

Study Overview
=================
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.

Official Title
-----------------
Added Value of Gadoxetic Acid-enhanced Liver Magnetic Resonance Imaging for Diagnosis of Small (10-19 mm) or Atypical Hepatic Nodules at Contrast-enhanced Computed Tomography: A Prospective Study

Conditions
-----------------
Hcc, Diagnosis

Intervention / Treatment
-----------------
* Procedure: gadoxetic acid-enhanced liver MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients group<br>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 | Procedure: gadoxetic acid-enhanced liver MRI<br>* liver MRI using a standard dose (0.025mmol/kg) of gadoxetic acid<br>|
| Living liver donor candidates<br>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 | Procedure: gadoxetic acid-enhanced liver MRI<br>* liver MRI using a standard dose (0.025mmol/kg) of gadoxetic acid<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity to diagnose HCC, per-nodule base | sensitivity of HCC on CT and gadoxetic acid MRI, per-nodule base | 12 months after MRI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| specificity to diagnose HCC, per-nodule base | specificity of HCC on CT and gadoxetic acid MRI, per-nodule base | 12 months after MRI | 
| sensitivity to diagnose HCC, per-patient base | sensitivity of HCC on CT and gadoxetic acid MRI, per-patient base | 12 months after MRI | 
| specificity to diagnose HCC, per-patient base | specificity of HCC on CT and gadoxetic acid MRI, per-patient base | 12 months after MRI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, gadoxetic acid, CT