Gadoxetic acid for the diagnosis of hepatocellular carcinoma in cirrhotic patients

Phase 1

• Conditions: hepatocellular carcinoma; MedDRA version: 14.1Level: LLTClassification code 10049010Term: Carcinoma hepatocellularSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2011-005909-79-ES
• Lead Sponsor: Fundació Clínic per a la Recerca Biomèdica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-28
• Last Update Posted: 6 February 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified