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

Phase 4

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: GADOXETIC ACID

• Registration Number: NCT01575574
• Lead Sponsor: Sara Varea

Brief Summary

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

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-03-27
• Study First Submitted QC: 2012-04-10
• Study First Posted: 2012-04-11
• Study Start: 2012-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-21
• Last Update Posted: 2016-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GADOXETIC ACID	GADOXETIC ACID	Is a non comparative study. a magnetic resonance will be done using gadoxetic acid : 0.025mmol/Kg

Primary Outcome Measures

Name	Time	Method
hepatocellular carcinoma diagnosed	1 month	Proportion of hepatocellular carcinoma diagnosed using gadoxetic acid magnetic resonance imaging (accuracy for diagnosis)

Secondary Outcome Measures

Name	Time	Method
magnetic resonance imaging sensitivity	9 months	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.

Trial Locations

Locations (1)

Hospital Clinic of Barcelona; 🇪🇸 Barcelona, Spain