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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00764387
First received: July 3, 2008
Last updated: July 3, 2012
Last verified: July 2012
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 164
Study Start Date: March 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Known neoplastic CNS lesions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00764387

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

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00764387     History of Changes
Other Study ID Numbers: 91780, 2007-005693-31, 312021
Study First Received: July 3, 2008
Last Updated: July 3, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Bayer:
Neoplastic CNS lesions
Contrast enhanced MRI
Comparison

ClinicalTrials.gov processed this record on May 16, 2013