Osteomyelitis MedDRA version: 9.1 Level: LLT Classification code 10031252 Term: Osteomyelitis
Conditions
Interventions
Trade Name: Gadovist 1.0 mmol/ml Injektionslösung
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Gadobutrol
Concentration unit: mmol/ml millimole(s)/millilitre
Concentration type: eq
Sponsors
Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to prove, that Gadovist 1.0 provides superior contrast enhancement characteristics of osteomyelitis in the bone of the distal lower limb 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 three-point scale (better, equal, worse) in a matched-pairs assessment from MR imaging examinations of all post-contrast T1-weighted images. | — |
Countries
Germany
Outcome results
None listed