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

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00764387
• Collaborator: (none)
• Enrollment: 166
• Locations: 12
• Arms: 2
• Duration (Months): 14
• Patients Per Site: 13.8
• Patients Per Site Per Month: 1

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Mar 1, 2008
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

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

Outcome Measures

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. [October 2007 to November 2008]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Known neoplastic CNS lesions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Andria	Bari	Italy	70031
2		Catania		Italy	95126
3		Chieti		Italy	66013
4		Messina		Italy	98122
5		Milano		Italy	20132
6		Napoli		Italy	80131
7		Novara		Italy	28100
8		Roma		Italy	00133
9		Roma		Italy	00168
10		Siena		Italy	53100
11		Trieste		Italy	34149
12		Verona		Italy	37136

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Click here and search for Bayer Product information provided by EMA

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00764387
• Other Study ID Numbers: 91780; 2007-005693-31; 312021
• First Posted: Oct 2, 2008
• Last Update Posted: Dec 5, 2014
• Last Verified: Dec 1, 2014

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

Study Results

No Results Posted as of Dec 5, 2014