Added Value of Gadoxetic Acid-enhanced Liver MRI

Status Completed

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03045419
Study type	Observational
Source	Seoul National University Hospital
Contact
Status	Completed
Phase	N/A
Start date	December 29, 2009
Completion date	December 31, 2016

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05845112` - Start Taking Action For TB Diagnosis
Not yet recruiting	`NCT05889312` - Assessing Cancer Treatment Response to Therapy Using 18F-FSPG PET
Completed	`NCT01194557` - Introducing Rapid Diagnostic Tests Into the Private Health Sector	N/A
Completed	`NCT04257955` - COMMUNIcation and Patient Engagement at Diagnosis of PAncreatic CAncer
Recruiting	`NCT05698212` - Proof of Concept Study to Eval MetriDx Lab-developed Test to Identify Endometriosis-specific Bio Markers	Phase 2
Recruiting	`NCT03372330` - Peripheral Artery Disease and Sepsis Outcomes	N/A
Active, not recruiting	`NCT06134011` - A Multi-omics-based Metabolic Typing Study of Gastric Cancer
Recruiting	`NCT06289803` - The Application of Probe Confocal Laser Endomicroscopy in Pancreatic Tumor Surgery	N/A
Not yet recruiting	`NCT06025240` - Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients
Not yet recruiting	`NCT05464576` - Tumor Staging T of Bladder Tumours: Correlation of MRI and Anatomopathologic Analysis	N/A
Completed	`NCT06185127` - Dexmedetomidine-ketamine Combination Versus Fentanyl-midazolam During Bronchoscopy	Phase 3
Recruiting	`NCT05824442` - Evaluation of a New Multiplex Quantitative PCR Technique for the Diagnosis of Echinococcosis	N/A
Not yet recruiting	`NCT06463223` - HIBOC = Hepatic Imaging Biomarkers in Obese Children
Not yet recruiting	`NCT06072820` - Analytical Evaluation of the Endotest® Diagnostic	N/A
Recruiting	`NCT05587114` - Comparision of Various Biomarkers Between Peripheral and Pulmonary Blood
Recruiting	`NCT06230458` - Fractional Exhaled Nitric Oxide (FeNO)- Test as add-on Test in the Diagnostic Work-up of Asthma	N/A
Not yet recruiting	`NCT05948410` - How Does the Mood of the Patients Change Before and After the Invasive Urodynamic Study?
Not yet recruiting	`NCT05947565` - Patient Position and Invasive Urodynamic Study Results in Males	N/A
Not yet recruiting	`NCT04490746` - Identifcation of Biomarkers for Active Pulmonary Tuberculosis
Completed	`NCT03381131` - Chinese Version of Fibromyalgia Criteria and Severity Scales Study

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.