Magnetic Resonance With Gadoxetic Acid for the Diagnosis of Hepatocellular Carcinoma in Patients With Liver Cirrhosis. Evaluation of Its Impact for the Non-invasive Diagnosis

Study Overview
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Brief Summary
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This is a study to evaluate the primovist as a new contrast agent useful to diagnostic of hepatocellular carcinoma

Detailed Description
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The investigators plan to define the imaging patterns of hepatocellular carcinoma in cirrhotic patients when studied with gadoxetic acid magnetic resonance imaging including the dynamic phase and the hepatobiliary phase at 10 and 20 minutes after contrast injection and to evaluate the usefulness of liver magnetic resonance imaging with gadoxetic acid in the differentiation between benign and malignant nodules in the cirrhotic liver. To determine the diagnosis and clinical significance of the infracentimetric additional nodules detected in the hepatobiliary phase

Official Title
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Magnetic Resonance With Gadoxetic Acid for the Diagnosis of Hepatocellular Carcinoma in Patients With Liver Cirrhosis. Evaluation of Its Impact for the Non-invasive Diagnosis

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: GADOXETIC ACID


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: more than 18 years old patient with diagnosis of liver cirrhosis Child Pugh A-B Patients without previous hepatocellular carcinoma in whom ultrasound detects a suspicious hepatic lesion; solitary solid and well-defined nodule between 10 and 20mm patients in whom diagnosis of hepatocellular carcinoma is a clinical need prior to treatment indication patient that agree to participate signing informed consent form Exclusion Criteria: Patients with poor liver function who would have undergone transplantation even without hepatocellular carcinoma diagnosis (Child-Pugh C) patients with previous diagnosis of hepatocellular carcinoma patients with significant comorbidities that could prevent the optimum therapeutic decision in case of positive diagnosis of hepatocellular carcinoma patients with severe clotting alterations that contraindicate the fine-needle biopsy -Patients with chronic kidney disease or glomerular filtration rate < 30 ml/min patients with contraindications to perform magnetic resonance imaging (pacemaker, claustrophobia...) Known hypersensitivity to study drugs or excipients pregnancy or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: GADOXETIC ACID<br>Is a non comparative study. a magnetic resonance will be done using gadoxetic acid : 0.025mmol/Kg | Drug: GADOXETIC ACID<br>* all patients will have a magnetic resonance with gadobutrol as reference for diagnosis; in participants an additional magnetic resonance will be done with the new contrast agent to verify if the diagnostic can be done.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hepatocellular carcinoma diagnosed | Proportion of hepatocellular carcinoma diagnosed using gadoxetic acid magnetic resonance imaging (accuracy for diagnosis) | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| magnetic resonance imaging sensitivity | magnetic resonance imaging sensitivity - number of patients that need fine-needle biopsy to the diagnosis. the patients would be followed until the diagnosis would be stablished. Is expected that this would be before 9 months. | 9 months |