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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)

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ClinicalTrials.gov Identifier: NCT01575574
Recruitment Status : Completed
First Posted : April 11, 2012
Last Update Posted : August 23, 2016
Sponsor:
Information provided by (Responsible Party):
Sara Varea, Fundacion Clinic per a la Recerca Biomédica

Study Description
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Brief Summary:
This is a study to evaluate the primovist as a new contrast agent useful to diagnostic of hepatocellular carcinoma

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: GADOXETIC ACID Phase 4

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2012
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arms and Interventions
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Arm Intervention/treatment
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.


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


Secondary Outcome Measures :
  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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575574


Locations
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Spain
Hospital Clinic of Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Sara Varea
Investigators
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Principal Investigator: Carmen Ayuso, Prof, PhD MD Hospital Clínic of Barcelona
More Information
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Responsible Party: Sara Varea, Clinical Research Manager, Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov Identifier: NCT01575574    
Other Study ID Numbers: PRIGA
2011-005909-79 ( EudraCT Number )
First Posted: April 11, 2012    Key Record Dates
Last Update Posted: August 23, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Liver Cirrhosis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases