Clinical trial · Interventional
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
NCT01575574CI-TRIAL-00023615PRIGAcompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a study to evaluate the primovist as a new contrast agent useful to diagnostic of hepatocellular carcinoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GADOXETIC ACID | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- GADOXETIC ACID
- description
- Is a non comparative study. a magnetic resonance will be done using gadoxetic acid : 0.025mmol/Kg
- interventionNames
- Drug: GADOXETIC ACID
Primary outcomes (1)
- measure
- hepatocellular carcinoma diagnosed
- timeFrame
- 1 month
- description
- Proportion of hepatocellular carcinoma diagnosed using gadoxetic acid magnetic resonance imaging (accuracy for diagnosis)
Secondary outcomes (1)
- measure
- magnetic resonance imaging sensitivity
- timeFrame
- 9 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.