Added Value of Gadoxetic Acid-enhanced Liver MRI

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

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 Overview

• Status: Completed
• Conditions: Diagnosis; Hcc
• Intervention / Treatment: Procedure: gadoxetic acid-enhanced liver MRI

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 Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients at a risk of HCC and had focal liver lesion at CT.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients group; 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; liver MRI using a standard dose (0.025mmol/kg) of gadoxetic acid
Living liver donor candidates; 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; liver MRI using a standard dose (0.025mmol/kg) of gadoxetic acid

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2009
• Primary Completion (Actual): November 24, 2013
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: February 3, 2017
• First Submitted That Met QC Criteria: February 3, 2017
• First Posted (Estimate): February 7, 2017

Study Record Updates

• Last Update Posted (Estimate): February 7, 2017
• Last Update Submitted That Met QC Criteria: February 3, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: MRI; gadoxetic acid; CT
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: SNUH-2009-5441

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No