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

NCT ID: NCT01575574

Last Updated: 2016-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2016-07-31

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

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

GADOXETIC ACID

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

Group Type: OTHER

GADOXETIC ACID

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sara Varea

OTHER

Sponsor Role: lead

Responsible Party

Sara Varea

Clinical Research Manager

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Carmen Ayuso, Prof, PhD MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínic of Barcelona

Locations

Hospital Clinic of Barcelona

Barcelona, Barcelona, Spain

Countries

Spain

Other Identifiers

2011-005909-79

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PRIGA

Identifier Type: -

Identifier Source: org_study_id