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 is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Fundacion Clinic per a la Recerca Biomédica
Sponsor:
Information provided by (Responsible Party):
Sara Varea, Fundació Clínic per la Recerca Biomèdica
ClinicalTrials.gov Identifier:
NCT01575574
First received: March 27, 2012
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: GADOXETIC ACID
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 Fundacion Clinic per a la Recerca Biomédica:

Primary Outcome Measures:
  • hepatocellular carcinoma diagnosed [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 70
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
GADOXETIC ACID
Is a non comparative study. a magnetic resonance will be done using gadoxetic acid : 0.025mmol/Kg
Drug: 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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01575574

Contacts
Contact: Carmen Ayuso, Prof, PhD, MD +34932275735 cayuso@clinic.ub.es
Contact: Sara Varea, B Sc +34932275400 ext 3343 svarea@clinic.ub.es

Locations
Spain
Hospital Clinic of Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Carmen Ayuso, MD PhD Prof       CAYUSO@clinic.ub.es   
Principal Investigator: Carmen Ayuso, MD phD Prof         
Sponsors and Collaborators
Sara Varea
Investigators
Principal Investigator: Carmen Ayuso, Prof, PhD MD Hospital Clínic of Barcelona
  More Information

No publications provided

Responsible Party: Sara Varea, Clinical Research Manager, Fundació Clínic per la Recerca Biomèdica
ClinicalTrials.gov Identifier: NCT01575574     History of Changes
Other Study ID Numbers: PRIGA, 2011-005909-79
Study First Received: March 27, 2012
Last Updated: April 8, 2014
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Liver Cirrhosis
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Gadolinium ethoxybenzyl DTPA
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014