patients with known or suspected biliary disease will be enrolled and image quality of the MR cholangiography images will be assessed after Primovist administration. Biliary disease can include: bile duct dilatation, ductal narrowing, filling defects, presence of ductal obstruction, presence of biliary leakage,...
Conditions
Interventions
Trade Name: Primovist
Pharmaceutical Form: Solution for injection
Sponsors
Erasme Hostpital - ULB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: known or suspected biliary disease and referred for endoscopic retrograde cholangiopancreatography (ERCP) 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: allergy for the active substance or known allergy for other contrast media, pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of image quality of contract-enhanced MR cholangiography using Primovist and determination of the optimal post injection time point for biliary tract imaging at 1.5 Tesla and 3 Tesla;Secondary Objective: Determination of diagnostic performance of contrast-enhanced MR cholangiography using Primovist at 1.5 Tesla and 3 Tesla for the evaluation of anatomic and functional biliary disorders;Primary end point(s): Assessment of the technical image quality and the optimal post injection time point for biliary tract imaging at 1.5 Tesla and 3 Tesla | — |
Countries
Belgium
Outcome results
None listed