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Clinical Trials/NCT00764387
NCT00764387
Completed
Phase 4

Contrast-enhanced MRI Examination of Cerebral Neoplastic Enhancing Lesions: Comparison of Diagnostic Efficacy of Gd-DOTA 0.5M and Gadobutrol 1.0 M at 0.1 mmol/kg Body Weight: Intraindividual Comparison Clinical Study.

Bayer0 sites166 target enrollmentMarch 2008

Overview

Phase
Phase 4
Intervention
Gadovist® (Gadobutrol, BAY86-4875)
Conditions
Neoplastic CNS Lesions
Sponsor
Bayer
Enrollment
166
Primary Endpoint
The primary analysis will be the comparison of the enhancements characteristics of Gadobutrol and Gd-TOTA on a lesion per lesion basis.
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Study to compare of two contrast agents in imaging brain lesions.

Registry
clinicaltrials.gov
Start Date
March 2008
End Date
May 2009
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Bayer
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Known neoplastic CNS lesions

Exclusion Criteria

  • Not provided

Arms & Interventions

Arm 1

Intervention: Gadovist® (Gadobutrol, BAY86-4875)

Arm 2

Intervention: Dotarem

Outcomes

Primary Outcomes

The primary analysis will be the comparison of the enhancements characteristics of Gadobutrol and Gd-TOTA on a lesion per lesion basis.

Time Frame: October 2007 to November 2008

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