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

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sara Varea

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