hepatocellular carcinoma MedDRA version: 14.1 Level: LLT Classification code 10049010 Term: Carcinoma hepatocellular System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Gadovist
Product Name: Gadovist
Pharmaceutical Form: Solution for injection
CAS Number: 138071-82-6
Other descriptive name: GADOBUTROL
Concentration unit: mmol/ml millimole(s)/millilitre
C
Sponsors
Fundació Clínic per a la Recerca Biomèdica
Eligibility
Sex/Gender
All
Inclusion 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 suspiciuos hepatic lesion; solitary solid and well-defined nodule between 10 and 20 mm - patients in whom diagnosis of hepatocellular carcinoma is a clinical need prior to treatment indication - patient that agree to parcicipate signing informed consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
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 comorbilities 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the diagnostic accuracy of magnetic resonance imaging with gadoxetate disodium for the diagnosis of hepatocellular carcinoma that do not fulfil the established diagnostic criteria as per current guidelines of AASLD (American Association for the Study of Liver Diseases);Secondary Objective: 1-To define the imaging patterns of hepatocellular carcinoma in cirrhotic patients when studied with gadoxetic acid magnetic resonance imaging including the dynamin phase and the hepatobiliary phase at 10 and 20 minutes after contrast injection 2- To evaluate the usefulness of liver magnetic resonance imaging with gadoxetic acid in the differenciation between bening and malignant nodules in the cirrhotic liver. 3- To determine the diagnosis and clinical significance of the infracentimetric additional nodules detected in the hepatobiliary phase;Primary end point(s): Proportion of hepatocellular carcinoma diagnosed using gadoxetic acid magnetic resonance imaging (accuracy for diagnosis);Timepoint(s) of evaluation of this end point: 1 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - magnetic resonance imaging sensitivity - number of patients that need fine-needle biopsy to the diagnosis;Timepoint(s) of evaluation of this end point: at the end of the study | — |
Countries
Spain
Contacts
Public ContactCTU Clinic (UASP)
Clinical Trials Unit (CTU)
Outcome results
None listed