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

Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH0 个研究点目标入组 50 人开始时间: 2008年5月30日最近更新: 2012年7月24日

适应症

试验速览

暂无简介。

•(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

•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.

发起方

Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH