Added Value of Gadoxetic Acid-enhanced Liver MRI

Diagnosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03045419
• Other study ID #: SNUH-2009-5441
• Status: Completed
• Phase: N/A
• First received: February 3, 2017
• Last updated: February 3, 2017
• Start date: December 29, 2009
• Est. completion date: December 31, 2016

Study information

• Verified date: February 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 31, 2016
• Est. primary completion date: November 24, 2013
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diagnosis
• Hcc

Intervention

Procedure:
• gadoxetic acid-enhanced liver MRI
liver MRI using a standard dose (0.025mmol/kg) of gadoxetic acid

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Bayer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity to diagnose HCC, per-nodule base	sensitivity of HCC on CT and gadoxetic acid MRI, per-nodule base	12 months after MRI
Secondary	specificity to diagnose HCC, per-nodule base	specificity of HCC on CT and gadoxetic acid MRI, per-nodule base	12 months after MRI
Secondary	sensitivity to diagnose HCC, per-patient base	sensitivity of HCC on CT and gadoxetic acid MRI, per-patient base	12 months after MRI
Secondary	specificity to diagnose HCC, per-patient base	specificity of HCC on CT and gadoxetic acid MRI, per-patient base	12 months after MRI