Study Completed

Neoplastic CNS lesions

Bayer Identifier:

91780

ClinicalTrials.gov Identifier:

NCT00764387

EudraCT Number:

2007-005693-31

EU CT Number:

Not Available

Contrast Enhanced MRI of the CNS - Patients with known cerebral neoplastic lesions.

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 Years

Trial summary

Enrollment Goal

166

Trial Dates

March 2008 - May 2009

Phase

Phase 4

Could I Receive a placebo

Products

Gadavist/Gadovist (Gadobutrol, BAY86-4875)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Novara, 28100, Italy
Completed		Verona, 37126, Italy
Completed		Napoli, 80131, Italy
Completed		Trieste, 34149, Italy
Completed		Barletta-Andria-Trani, 70031, Italy
Completed		Milano, 20132, Italy
Completed		Roma, 00168, Italy
Completed		Chieti, 66100, Italy
Completed		Catania, 95126, Italy
Completed		Messina, 98125, Italy
Completed		Siena, 53100, Italy
Completed		Roma, 00133, Italy

Primary Outcome

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
Safety Issue:
no

Trial design

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.

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Diagnostic

Allocation

Randomized

Blinding

Single Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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