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 (PRIGA)

Sara Varea

Status and phase

Completed

Phase 4

Conditions

Hepatocellular Carcinoma

Treatments

Drug: GADOXETIC ACID

Study type

Interventional

Funder types

Other

Identifiers

NCT01575574

PRIGA

2011-005909-79 (EudraCT Number)

Details and patient eligibility

About

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

Full 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

Enrollment

74 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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