Clinical trial · Observational
Utility Study of Primovist-MRI on HCC Staging
The Incidence of Change in BCLC Stage by add-on Primovist-enhanced MRI During Initial Staging Work-up in HCC Patients Who Can be Candidates for Curative Treatment by Liver Dynamic CT: A Prospective Multicenter Study
NCT01764438CI-TRIAL-00008832PrimovistMRIunknownClinicalTrials.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)
Gadoxetic acid (Gd-EOB-DTPA, Primovist)-enhanced MRI can affect on BCLC staging during the initial staging workups of definite HCC patients with very early or early stage disease, but with no suspicious intrahepatic HCC lesions by liver dynamic CT.
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 |
|---|---|---|---|
| Primovist-enhanced MRI | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- very early or early staged patients
- description
- Performance of Primovist-enhanced MRI in HCC patients with very early or early stage disease, but with no suspicious HCC by liver dynamic CT
- interventionNames
- Procedure: Primovist-enhanced MRI
Primary outcomes (1)
- measure
- incidence of change of BCLC stage after add-on Primovist-enhanced MRI in HCC patients with very early or early stage disease, but with no suspicious intrahepatic HCC lesions by liver dynamic CT.
- timeFrame
- Performance of Primovist enhanced MRI within the first 7 days after liver dynamic CT
Secondary outcomes (4)
- measure
- Incidence of newly detected intrahepatic HCC lesionss by Primovist-enhanced MRI, but, these lesions were not detected by liver dynamic CT
- timeFrame
- Performance of Primovist-enhacned MRI within 7 days after liver dynamic CT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years ≤ age * Patients who are initially diagnosed as having hepatocellular carcinoma with very early or early BCLC stage by liver dynamic CT at each hospital * Performance status 0 or 1 * Child-Turcotte-Pugh score ≤8 Exclusion Criteria: * Age of younger than 18 * Patients with any concurrent cancer other than hepatocellular carcinoma. Any cancer curatively treated at least 3 years prior to entry is permitted. * Patients with BCLC B, C, or D staged HCC at initial diagnosis by liver dynamic CT * Patients with suspicious intrahepatic malignant lesion by liver dynamic CT * Patients with HIV infection * Female patients in pregnancy * Clinically hemodyanmically unstable patients * Patients with previous life-threatening anaphylactic reaction to contrast media * Patients scheduled for biopsy or liver surgery within 24 h post-administration of the study * Patients who cannot underwent CT due to renal insufficiency (estimated GFR \< 30 mL/min/1.73m2) * Patients who cannot perform MRI due to contraindication of MRI (e.g. an implanted cardiac pacemaker) * Patients in whom MRI was performed before liver dynamic CT
References
Publications (0)
Data not yet available
No reference posted for this study.