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 is a study to evaluate the primovist as a new contrast agent useful to diagnostic of hepatocellular carcinoma
|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|
- 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)
- 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.
|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)|
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.
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
|Contact: Carmen Ayuso, Prof, PhD, MDfirstname.lastname@example.org|
|Contact: Sara Varea, B Sc||+34932275400 ext email@example.com|
|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|
|Principal Investigator:||Carmen Ayuso, Prof, PhD MD||Hospital Clínic of Barcelona|