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: June 19, 2013
Last verified: June 2013
  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:


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
ASL BAT Andria - Puglia
Andria, Bari, Italy, 70031
A.O. Cannizzaro
Catania, Italy, 95126
Università G.D'Annunzio
Chieti, Italy, 66013
A.O.U. Policlinico Martino
Messina, Italy, 98122
IRCCS Fondazione San Raffaele
Milano, Italy, 20132
A.O.U. Seconda Università
Napoli, Italy, 80131
A.O.U. Maggiore della Carità
Novara, Italy, 28100
Università Cattolica del Sacro Cuore
Roma, Italy, 00168
A.O.U. Policlinico Tor Vergata
Roma, Italy, 00133
A.O.U. Senese
Siena, Italy, 53100
A.O.U. Ospedali Riuniti Trieste
Trieste, Italy, 34149
A.O.U. Ist.Ospitalieri Verona
Verona, Italy, 37136
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
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: June 19, 2013
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on April 21, 2014