Patients with clinically definite MS or a clinically isolated episode of CNS involvement and disease dissemination in space, according to the McDonald’s criteria MedDRA version: 12.0 Level: LLT Classification code 10028245 Term: Multiple sclerosis
Conditions
Interventions
Trade Name: Gadovist 1.0 mmol/ml Injektionslösung
Product Code: V08CA09
Pharmaceutical Form: Solution for injection
INN or Proposed INN: GADOBUTROL
CAS Number: 138071-82-6
Other descriptive name: GADO
Sponsors
Universitätsklinikum Erlangen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. adult patients, age 18-85 years 2. with clinically definite MS or a clinically isolated episode of CNS involvement and disease dissemination in space, according to the McDonald’s criteria, 3. and known or suspected active MS lesion(s) of the brain or spine 4. planned MR examination of the brain with 0.1 mmol Gd per kg bw 5. willing to undergo and comply with all study procedures 6. have voluntarily given 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: Patients … 1. who are in pregnancy or nursery. In women with child bearing potential a pregnancy test must be performed directly before each MR examination in order to safely exclude pregnancy. The manufacturer’s instructions for performing the urinary pregnancy test are to be followed. 2. with impaired renal function of CKD stadium 3 and higher (i.e. creatinine clearance <60 ml/min/1.73m² (Cockroft-Gault formula) or patients on hemodialysis. In patients with known renal impairment, clearance will be calculated based on serum creatinine level using the Cockroft-Gault formula. Calculation of the clearance must be done before begin of study. Serum creatinine value must not be older than one week (7 days) before study related contrast injection. 3. with severely impaired hepatic function (e.g. SGPT ? 2 times the upper limit of reference range) 4. with renal or liver transplant, including patients with scheduled liver transplant 5. with known allergy or any contraindication to Gadobutrol or Gadoterate. 6. presenting with a history of anaphylactoid or anaphylactic reaction to any allergen, including drugs and contrast agents. 7. with high grade cardiac arrhythmia 8. not being able to remain lying down for at least 30-45 min (e.g., patients with unstable angina, dyspnoea at rest, severe pain at rest, severe back pain) 9. having any physical or mental status that interferes with the informed consent procedure including self-signed consent. 10. with a contraindication for MRI (pacemaker, magnetic clips, severe claustrophobia etc.) 11. being clinically unstable or requiring emergency treatment 12. with close affiliation with the investigational site; e.g. a close relative of the investigator 13. who have received any investigational drug within 7 days prior to entering this study 14. who have received any contrast agent within 24 hours prior to entering this study 15. who have previously entered this study 16. participating in another clinical trial 17. who are scheduled for any therapy between any of the study procedures that may interfere with the comparability of the study procedures. Especially patients must not receive any steroids between the two examinations. 18. having an underlying disease or concomitant medication which may interfere with efficacy evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to prove, that Gadovist® 1.0 provides superior contrast enhancement characteristics of MS lesions as compared to Dotarem®, thereby providing superior information for further diagnostic and / or therapeutic decisions. ;Secondary Objective: ;Primary end point(s): Overall assessment of contrast enhancement on a 3-point scale (equal – better – worse) in a matched pair assessment of both contrast agents. | — |
Countries
Germany
Outcome results
None listed