Hepatocellular Carcinoma
Conditions
Brief summary
This is a study to evaluate the primovist as a new contrast agent useful to diagnostic of hepatocellular carcinoma
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
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.
Sponsors
Sara Varea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hepatocellular carcinoma diagnosed | 1 month | Proportion of hepatocellular carcinoma diagnosed using gadoxetic acid magnetic resonance imaging (accuracy for diagnosis) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| magnetic resonance imaging sensitivity | 9 months | 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. |
Countries
Spain
Outcome results
None listed