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Completed

NCT Number: NCT03045419

Added Value of Gadoxetic Acid-enhanced Liver MRI

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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gadoxetic acid-enhanced liver MRI

Procedure

liver MRI using a standard dose (0.025mmol/kg) of gadoxetic acid

Primary outcomes

  1. sensitivity to diagnose HCC, per-nodule base

    Time frame: 12 months after MRI

    sensitivity of HCC on CT and gadoxetic acid MRI, per-nodule base

Secondary outcomes

  1. specificity to diagnose HCC, per-nodule base

    Time frame: 12 months after MRI

    specificity of HCC on CT and gadoxetic acid MRI, per-nodule base

  2. sensitivity to diagnose HCC, per-patient base

    Time frame: 12 months after MRI

    sensitivity of HCC on CT and gadoxetic acid MRI, per-patient base

  3. specificity to diagnose HCC, per-patient base

    Time frame: 12 months after MRI

    specificity of HCC on CT and gadoxetic acid MRI, per-patient base

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Bayer

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2013
Study completion
2016
First posted
Feb 7, 2017
Registry last updated
Feb 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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