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

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00764387

Enrollment

166

Registered

2008-10-02

Start date

2008-03-31

Completion date

2009-05-31

Last updated

2014-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplastic CNS Lesions

Keywords

Neoplastic CNS lesions, Contrast enhanced MRI, Comparison

Brief summary

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

Interventions

DRUGGadovist® (Gadobutrol, BAY86-4875)

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

DRUGDotarem

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Known neoplastic CNS lesions

Design outcomes

Primary

Measure	Time frame
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026