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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)

This study has been completed.
Information provided by (Responsible Party):
Sara Varea, Fundació Clínic per la Recerca Biomèdica Identifier:
First received: March 27, 2012
Last updated: August 21, 2016
Last verified: August 2016
This is a study to evaluate the primovist as a new contrast agent useful to diagnostic of hepatocellular carcinoma

Condition Intervention Phase
Hepatocellular Carcinoma
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Sara Varea, Fundació Clínic per la Recerca Biomèdica:

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

Secondary Outcome 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.

Enrollment: 74
Study Start Date: July 2012
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Is a non comparative study. a magnetic resonance will be done using gadoxetic acid : 0.025mmol/Kg
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.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01575574

Hospital Clinic of Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Sara Varea
Principal Investigator: Carmen Ayuso, Prof, PhD MD Hospital Clínic of Barcelona
  More Information

Responsible Party: Sara Varea, Clinical Research Manager, Fundació Clínic per la Recerca Biomèdica Identifier: NCT01575574     History of Changes
Other Study ID Numbers: PRIGA
2011-005909-79 ( EudraCT Number )
Study First Received: March 27, 2012
Last Updated: August 21, 2016

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Cirrhosis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases processed this record on May 25, 2017