Intra-individual, randomized comparison of the MRI contrast agents Gadovist 1.0 versus Dotarem in imaging the distal lower limb of patients with known or suspicion of osteomyelitis, evaluated in a blinded read

• Conditions: Osteomyelitis; MedDRA version: 9.1Level: LLTClassification code 10031252Term: Osteomyelitis

• Registration Number: EUCTR2008-002741-23-DE
• Lead Sponsor: Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-30
• Last Update Posted: 24 July 2012

Recruitment & Eligibility

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

Inclusion Criteria

(Diabetic) patients with diagnosis or suspicion of having osteomyelitis, indicated for contrast enhanced MRI
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 ? 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. Serum creatinine value must not be older than one week (7 days) before study related contrast injection.
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