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 Clinical Trial

— PRIGA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01575574
• Other study ID #: PRIGA
• Secondary ID: 2011-005909-79
• Status: Completed
• Phase: Phase 4
• First received: March 27, 2012
• Last updated: August 21, 2016
• Start date: July 2012
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

This is a study to evaluate the primovist as a new contrast agent useful to diagnostic of hepatocellular carcinoma

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Fibrosis
• Hepatocellular Carcinoma
• Liver Cirrhosis

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Clinic of Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Sara Varea

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hepatocellular carcinoma diagnosed	Proportion of hepatocellular carcinoma diagnosed using gadoxetic acid magnetic resonance imaging (accuracy for diagnosis)	1 month	No
Secondary	magnetic resonance imaging sensitivity	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.	9 months	No