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

Arm | Intervention/treatment |
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GADOXETIC ACID
Is a non comparative study. a magnetic resonance will be done using gadoxetic acid : 0.025mmol/Kg
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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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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

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
Spain | |
Hospital Clinic of Barcelona | |
Barcelona, Spain, 08036 |
Principal Investigator: | Carmen Ayuso, Prof, PhD MD | Hospital Clínic of Barcelona |
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 |
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 |