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Clinical Trials/EUCTR2008-002741-23-DE
EUCTR2008-002741-23-DE
Active, not recruiting
Not Applicable

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 sites50 target enrollmentMay 30, 2008
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DrugsGadovist 1.0 mmol/ml InjektionslösungDOTAREM 0,5 mmol/ml Injektionslösung

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH
Enrollment
50
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 30, 2008
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH

Eligibility 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

  • •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.

Outcomes

Primary Outcomes

Not specified

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