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OpenTrials
Completed

NCT Number: NCT00764387

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Andria, Bari, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Known neoplastic CNS lesions

Treatment and study plan

Gadovist® (Gadobutrol, BAY86-4875)

Drug

0,1 mmol/kg of body weight in the vein, single administration

DOTAREM

Drug

0,1 mmol/kg of body weight in the vein, single administration

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 2, 2008
Registry last updated
Dec 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.