Patients with clinical-echographical suspect of biliary pathology and pre-existing bilo-enteric anastomoses. MedDRA version: 9.1 Level: HLT Classification code 10019808 Term: Hepatobiliary imaging procedures
Conditions
Interventions
Trade Name: PRIMOVIST
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Gadoxetic acid
Concentration unit: mmol/ml millimole(s)/millilitre
Concentration type: equal
Concentration number
Sponsors
AZIENDA OSPEDALIERA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult (18 years and older) patients (men or women of any ethnic group). 2. Patients with clinical-echographical suspect of biliary pathology. 3. Patients with pre-existing bilo-enteric anastomoses. 4. Patients willing and able to undergo all study procedures. 5. Women in fertile age that use contraceptives. 6. Patients who have signed the written informed consent. 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: 1. Pregnant or lactating women. 2. Patients with less than 3 months life expectation. 3. Patients presenting with contraindication to MR. 4. Patients with cardiac pacemakers and ferromagnetic implants 5. Patients taking class III antiarrhythmic and rifampicin 6. Patients with uncorrected hypokalemia or hypopotassemia 7. History of allergic disorder (of any severity) or allergic reaction to MR contrast media. 8.Patients with history of bronchial asthma and severe cardiovascular problem 9. Uncooperative, in the investigator?s opinion. 10. Severe renal impairment (GFR< 30ml/min /1.73 m2). 11. Severe hepatic impairment. 12. Participating in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to assess the added efficacy of Primovist in MRCP in comparison to the conventional T2-weighted MRCP in depicting the biliary pathology in patients with pre-existing bilo-enteric anastomoses. The reference method is surgery finding, if scheduled, and/or a six-months-lasting clinical-radiological follow-up.;Secondary Objective: The secondary study objective is to monitor the incidence of AE in MR procedure.;Primary end point(s): Concordance rate between experimental procedures and reference standard results on a per patient basis. An exam will be considered concordant with the reference standard if the results in term of diagnostic findings will be exactly the same. | — |
Countries
Italy
Outcome results
None listed