Diagnosis, Hcc
Conditions
Keywords
MRI, gadoxetic acid, CT
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.
Interventions
PROCEDUREgadoxetic acid-enhanced liver MRI
liver MRI using a standard dose (0.025mmol/kg) of gadoxetic acid
Sponsors
Bayer
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sensitivity to diagnose HCC, per-nodule base | 12 months after MRI | sensitivity of HCC on CT and gadoxetic acid MRI, per-nodule base |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| specificity to diagnose HCC, per-nodule base | 12 months after MRI | specificity of HCC on CT and gadoxetic acid MRI, per-nodule base |
| sensitivity to diagnose HCC, per-patient base | 12 months after MRI | sensitivity of HCC on CT and gadoxetic acid MRI, per-patient base |
| specificity to diagnose HCC, per-patient base | 12 months after MRI | specificity of HCC on CT and gadoxetic acid MRI, per-patient base |
Countries
South Korea
Outcome results
None listed