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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2016

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

Interventions

  • Drug: GADOXETIC ACID
    • 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • hepatocellular carcinoma diagnosed
    • Time Frame: 1 month
    • Proportion of hepatocellular carcinoma diagnosed using gadoxetic acid magnetic resonance imaging (accuracy for diagnosis)

Secondary Measures

  • magnetic resonance imaging sensitivity
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sara Varea
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Sara Varea, Clinical Research Manager – Fundacion Clinic per a la Recerca Biomédica
  • Overall Official(s)
    • Carmen Ayuso, Prof, PhD MD, Principal Investigator, Hospital Clínic of Barcelona

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