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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


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

hepatocellular carcinoma diagnosed

Outcome Description:

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

Outcome Time Frame:

1 month

Safety Issue:

No

Principal Investigator

Carmen Ayuso, Prof, PhD MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital ClĂ­nic of Barcelona

Authority:

Spain: Spanish Agency of Medicines

Study ID:

PRIGA

NCT ID:

NCT01575574

Start Date:

July 2012

Completion Date:

July 2014

Related Keywords:

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

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