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Trial record 12 of 44 for:    Gadoxetate

Added Value of Gadoxetic Acid-enhanced Liver MRI

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ClinicalTrials.gov Identifier: NCT03045419
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : February 7, 2017
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Jeong Min Lee, Seoul National University Hospital

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.


Condition or disease Intervention/treatment
Hcc Diagnosis 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.


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Study Type : Observational
Actual Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : December 29, 2009
Actual Primary Completion Date : November 24, 2013
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
patients at a risk of HCC and had focal liver lesion at CT.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045419


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Bayer
Investigators
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Principal Investigator: Jeong Min Lee, MD Seoul National University Hospital

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Responsible Party: Jeong Min Lee, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03045419     History of Changes
Other Study ID Numbers: SNUH-2009-5441
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeong Min Lee, Seoul National University Hospital:
MRI
gadoxetic acid
CT
Additional relevant MeSH terms:
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Liver Extracts
Hematinics