Skip to main content
OpenTrials
Completed

NCT Number: NCT01575574

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GADOXETIC ACID

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.

Primary outcomes

  1. hepatocellular carcinoma diagnosed

    Time frame: 1 month

    Proportion of hepatocellular carcinoma diagnosed using gadoxetic acid magnetic resonance imaging (accuracy for diagnosis)

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Sara Varea

Other

Registry information

Acronym: PRIGA

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Apr 11, 2012
Registry last updated
Aug 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.