Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00764387
Recruitment Status : Completed
First Posted : October 2, 2008
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE July 3, 2008
First Posted Date  ICMJE October 2, 2008
Last Update Posted Date December 5, 2014
Study Start Date  ICMJE March 2008
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Contrast Enhanced MRI of the CNS - Patients With Known Cerebral Neoplastic Lesions.
Official Title  ICMJE 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.
Brief Summary Study to compare of two contrast agents in imaging brain lesions.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Condition  ICMJE Neoplastic CNS Lesions
Intervention  ICMJE
  • Drug: Gadovist® (Gadobutrol, BAY86-4875)
    0,1 mmol/kg of body weight in the vein, single administration
  • Drug: Dotarem
    0,1 mmol/kg of body weight in the vein, single administration
Study Arms  ICMJE
  • Experimental: Arm 1
    Intervention: Drug: Gadovist® (Gadobutrol, BAY86-4875)
  • Active Comparator: Arm 2
    Intervention: Drug: Dotarem
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2014)
166
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2008)
145
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Known neoplastic CNS lesions
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00764387
Other Study ID Numbers  ICMJE 91780
2007-005693-31 ( EudraCT Number )
312021 ( Other Identifier: Company Internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP