Safety and Efficacy of Gadobutrol 1.0 Molar (Gadovist®) in Patients Forr Central Nervous System (CNS) Imaging - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00623467

Purpose

This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Gadovist®. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadovist® when used for taking images of the brain and spine. The results of the MRI will be compared to the results of images taken without Gadovist®.

Condition	Intervention	Phase
Central Nervous System Diseases	Drug: Gadovist (Gadobutrol, BAY86-4875)	Phase III

MedlinePlus related topics: MRI Scans Neurologic Diseases

Drug Information available for: Gadobutrol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Open-Label, Phase 3 Study to Determine the Safety and Efficacy of Gadobutrol 1.0 Molar (Gadovist®) in Patients Referred for Contrast-Enhanced MRI of the Central Nervous System (CNS).

Further study details as provided by Bayer:

Primary Outcome Measures:

Demonstrate improvement of combined unenhanced and gadobutrol-enhanced magnetic resonance imaging (MRI) compared to unenhanced MRI [ Time Frame: Study duration approximately 12 months, patient duration in the study 72 hours. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Demonstrate improvement of gadobutrol-enhanced MRI to unenhanced MRI for: Exact match of the MR diagnoses with the final clinical diagnosis; [ Time Frame: Study duration is approximately 12 months, Patient completion is 72 hours ] [ Designated as safety issue: No ]
Detection of normal/abnormal brain tissue. [ Time Frame: Study duration is approximately 12 months, Patient completion is 72 hours ] [ Designated as safety issue: No ]
Sensitivity and specificity for the detection of malignant CNS lesions; [ Time Frame: Study duration is approximately 12 months, Patient completion is 72 hours ] [ Designated as safety issue: No ]
Confidence in diagnosis; [ Time Frame: Study duration is approximately 12 months, Patient completion is 72 hours ] [ Designated as safety issue: No ]
The number of contrast-enhanced lesions [ Time Frame: Study duration is approximately 12 months, Patient completion is 72 hours ] [ Designated as safety issue: No ]
Assess the safety profile of gadobutrol after IV administration [ Time Frame: Study duration is approximately 12 months, Patient completion is 72 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	December 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Gadovist (Gadobutrol, BAY86-4875) Gadobutrol single injection 0.1 mmol/kg BW via IV bolus administration at 2mL/sec.

Eligibility

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

Criteria

Inclusion Criteria:

Patients referred for contrast enhanced MRI of the CNS based on symptoms or previous procedures.

Exclusion Criteria:

Patients with acute renal insufficiency
Patients with severe renal disease
Patients with any contraindication to magnetic resonance imaging.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623467

Contacts

Contact: Bayer Clinical Trial Contact		clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4')	(+) 1-888-84 22937

Show 26 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Manager

Bayer

More Information

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Responsible Party:	Bayer HealthCare Pharmaceuticals Inc ( Therapeutic Area Head )
Study ID Numbers:	91682
Study First Received:	February 18, 2008
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00623467
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Central Nervous System Imaging
Diagnostic Imaging

Study placed in the following topic categories:

Central Nervous System Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009