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CompletedNCT01575574PRIGAUpdated Aug 23, 2016

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

A Phase 4 interventional study of GADOXETIC ACID in Hepatocellular Carcinoma, sponsored by Sara Varea. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-23.

Sponsored by Sara Varea · Phase 4, Interventional, and Diagnostic

Phase
Phase 4
Study type
Interventional
Enrollment
74
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Hepatocellular Carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 74 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Sara Varea is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
74 participants (actual)

Study arms

  • Other
    GADOXETIC ACID

    Is a non comparative study. a magnetic resonance will be done using gadoxetic acid : 0.025mmol/Kg

    Drug: GADOXETIC ACID

Interventions

  • DrugGADOXETIC 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.

06

What researchers measure

Primary outcomes

  1. hepatocellular carcinoma diagnosed

    Proportion of hepatocellular carcinoma diagnosed using gadoxetic acid magnetic resonance imaging (accuracy for diagnosis)

    Time frame: 1 month

Secondary outcomes

  1. 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.

    Time frame: 9 months

07

Study locations

1 site
  • Hospital Clinic of Barcelona
    Barcelona, 08036, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01575574
Lead sponsor
Sara Varea
Responsible party
Sara Varea (Clinical Research Manager, Fundacion Clinic per a la Recerca Biomédica) — Sponsor-investigator
First posted
Apr 11, 2012
Start date
Jul 2012
Primary completion
Jul 2016
Completion
Jul 2016
Last update
Aug 23, 2016

Study contacts

Carmen Ayuso, Prof, PhD MD
principal investigator · Hospital Clínic of Barcelona

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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