Intra-individual, randomized comparison of the MRI contrast agents Gadovist 1.0 versus Dotarem when imaging the pelvis in patients with spondylarthritides, evaluated in a blinded read

Conditions: Polyarthritis
MedDRA version: 9.1Level: LLTClassification code 10046107Term: Unspecified polyarthropathy or polyarthritis involving pelvic region and thigh

Registration Number: EUCTR2007-004222-24-DE

Lead Sponsor: Dekan des FB Medizin der Johann-Wolfgang Goethe-Universität

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 60

Inclusion Criteria

•Patients (> 18 yrs) with known or who are highly suspicious of having Spondylarthritides (SpA) with axial involvement and inflammatory back pain and are indicated for contrast-enhanced MRI of the pelvis
•Patients who are willing to undergo study procedures
•Patients who are willing and able to sign 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 who have previously entered this study
•Patients 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.
•Patients with any physical or mental status that interferes with the signing of informed consent
•Patients with a contraindication for MRI
•Patients who have received any contrast material within 12 hours prior to injection with study, comparator or similar drug in combination with moderate or severe renal impairment.
•Patients who require emergency treatment
•Patients with severely impaired hepatic function (e.g. SGPT equal or more than 2 times the upper limit of reference range)
•Patients with impaired renal function of CKD stadium 3 and higher (e.g. creatinine clearance < 60ml/ min). 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.
•Patients with underlying disease or concomitant medication which may interfere with efficacy evaluation
•Patients with known anaphylactoid or anaphylactic reaction to any contrast media.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to prove, that Gadovist® 1.0 provides superior contrast enhancement characteristics of inflammatory tissue in the pelvis as compared to Dotarem®, thereby providing superior information for further diagnostic and/ or therapeutic decisions.;Secondary Objective: ;Primary end point(s): Technical (quantitative) assessment of the change of…<br>• Signal intensity of the bone in post-contrast T1-weighted images measured in the second T1 VIBE sequence after contrast administration

Secondary Outcome Measures