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
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: GADOXETIC ACID||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- hepatocellular carcinoma diagnosed [ Time Frame: 1 month ]Proportion of hepatocellular carcinoma diagnosed using gadoxetic acid magnetic resonance imaging (accuracy for diagnosis)
- 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.
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
|Hospital Clinic of Barcelona|
|Barcelona, Spain, 08036|
|Principal Investigator:||Carmen Ayuso, Prof, PhD MD||Hospital Clínic of Barcelona|