Intra-individual, randomized multicentric comparison of the MRI contrast agents Gadovist 1.0 versus Dotarem in patients with Multiple Sclerosis at 3T - Gadovist in MS

Phase 1

• Conditions: 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: 12.0Level: LLTClassification code 10028245Term: Multiple sclerosis

• Registration Number: EUCTR2009-014857-34-DE
• Lead Sponsor: niversitätsklinikum Erlangen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-12-21
• Study Completion: 2011-01-01
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>;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.