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

NCT ID: NCT00764387

Last Updated: 2014-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-05-31

Brief Summary

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

Detailed Description

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Conditions

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Neoplastic CNS Lesions

Keywords

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Neoplastic CNS lesions Contrast enhanced MRI Comparison

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Gadovist® (Gadobutrol, BAY86-4875)

Intervention Type DRUG

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

Arm 2

Group Type ACTIVE_COMPARATOR

Dotarem

Intervention Type DRUG

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

Interventions

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Gadovist® (Gadobutrol, BAY86-4875)

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

Intervention Type DRUG

Dotarem

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Known neoplastic CNS lesions
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Andria, Bari, Italy

Site Status

Catania, , Italy

Site Status

Chieti, , Italy

Site Status

Messina, , Italy

Site Status

Milan, , Italy

Site Status

Napoli, , Italy

Site Status

Novara, , Italy

Site Status

Roma, , Italy

Site Status

Roma, , Italy

Site Status

Siena, , Italy

Site Status

Trieste, , Italy

Site Status

Verona, , Italy

Site Status

Countries

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Italy

Related Links

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http://www.clinicaltrialsregister.eu

Click here and search for Bayer Product information provided by EMA

Other Identifiers

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2007-005693-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

312021

Identifier Type: OTHER

Identifier Source: secondary_id

91780

Identifier Type: -

Identifier Source: org_study_id