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.
Verified February 2013 by Fundacion Clinic per a la Recerca Biomédica
Sponsor:
Sara Varea
Information provided by (Responsible Party):
Sara Varea, Fundació Clínic per la Recerca Biomèdica
ClinicalTrials.gov Identifier:
NCT01575574
First received: March 27, 2012
Last updated: February 15, 2013
Last verified: February 2013
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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:
Genetics Home Reference related topics:
North American Indian childhood cirrhosis
MedlinePlus related topics:
Cirrhosis
Drug Information available for:
Gadoxetate Disodium
U.S. FDA Resources
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
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: | February 15, 2013 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Additional relevant MeSH terms:
|
Carcinoma Fibrosis Liver Cirrhosis Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Pathologic Processes Liver Diseases Digestive System Diseases Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site |
ClinicalTrials.gov processed this record on May 23, 2013