E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with clinical-echographical suspect of biliary pathology and pre-existing bilo-enteric anastomoses. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10019808 |
E.1.2 | Term | Hepatobiliary imaging procedures |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
The secondary study objective is to monitor the incidence of AE in MR procedure. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
|
E.4 | Principal 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 investigators opinion. 10. Severe renal impairment (GFR< 30ml/min /1.73 m2). 11. Severe hepatic impairment. 12. Participating in another clinical trial. |
|
E.5 End points |
E.5.1 | 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. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
CPRM convenzionale T2-pesata |
|
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |