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Contrast Enhanced MRI of the CNS - Patients With Known Cerebral Neoplastic Lesions.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00764387
Recruitment Status : Completed
First Posted : October 2, 2008
Last Update Posted : December 5, 2014
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Neoplastic CNS Lesions Drug: Gadovist® (Gadobutrol, BAY86-4875) Drug: Dotarem Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: 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.
Study Start Date : March 2008
Primary Completion Date : May 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Gadobutrol
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1 Drug: Gadovist® (Gadobutrol, BAY86-4875)
0,1 mmol/kg of body weight in the vein, single administration
Active Comparator: Arm 2 Drug: Dotarem
0,1 mmol/kg of body weight in the vein, single administration

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Known neoplastic CNS lesions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00764387

Andria, Bari, Italy, 70031
Catania, Italy, 95126
Chieti, Italy, 66013
Messina, Italy, 98122
Milano, Italy, 20132
Napoli, Italy, 80131
Novara, Italy, 28100
Roma, Italy, 00133
Roma, Italy, 00168
Siena, Italy, 53100
Trieste, Italy, 34149
Verona, Italy, 37136
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT00764387     History of Changes
Other Study ID Numbers: 91780
2007-005693-31 ( EudraCT Number )
312021 ( Other Identifier: Company Internal )
First Posted: October 2, 2008    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

Keywords provided by Bayer:
Neoplastic CNS lesions
Contrast enhanced MRI