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Clinical Trials/EUCTR2007-002888-27-DE
EUCTR2007-002888-27-DE
Active, not recruiting
Not Applicable

Intra-individual, randomized comparison of the MRI contrast agents Gadovist® 1.0 versus Prohance® in patients with primary and secondary brain tumors, evaluated in a blinded read

Knappschaftskrankenhaus Bochum0 sitesJuly 8, 2008
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DrugsGadovist 1.0 mmol/ml InjektionslösungProHance 0,5 M, Injektionslösung

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Knappschaftskrankenhaus Bochum
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 8, 2008
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Knappschaftskrankenhaus Bochum

Eligibility Criteria

Inclusion Criteria

  • •Patients (\> 18 yrs) with known CNS lesion(s) indicated for contrast enhanced MRI for diagnosis and are scheduled for neurosurgical treatment
  • •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 or are suspected in pregnancy or nursery
  • •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 in 12 hours prior to injection with study or comparator drug in combination with moderate or severe renal impairment.
  • •Patients who require emergency treatment
  • •Patients with severely impaired hepatic or renal functions (e.g. SGPT ? 2 times the upper limit of reference range, acute renal failure)
  • •Patients with underlying disease or concomitant medication which may interfere with efficacy evaluation
  • •Patients who are scheduled for CNS surgery or who would have a biopsy prior to the second planned injection of contrast medium
  • •Patients with known anaphylactoid or anaphylactic reaction to any contrast media

Outcomes

Primary Outcomes

Not specified

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