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

NCT01575574 | Completed Phase 4

• 2 other identifiers: PRIGA2011-005909-79
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• hepatocellular carcinoma diagnosed

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

  1 month

Secondary Outcomes (1)

• magnetic resonance imaging sensitivity

  9 months

Study Arms (1)

GADOXETIC ACID

OTHER

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

Drug: GADOXETIC ACID

Interventions

GADOXETIC ACID DRUG

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.

GADOXETIC ACID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sara Varea: lead

Study Sites (1)

Hospital Clinic of Barcelona

Barcelona, Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

gadolinium ethoxybenzyl DTPA

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Carmen Ayuso, Prof, PhD MD

  Hospital Clínic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Manager

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: April 11, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 23, 2016

Record last verified: 2016-08

Locations

ES (1)