Patient Characteristics in Daily Radiological Practice of Gadovist® Application (PATRON)

Completed

• Conditions: Epidemiologic Factors
• Interventions: Biological: Gadobutrol (Gadovist, BAY86-4875)

• Registration Number: NCT00874640
• Lead Sponsor: Bayer

Brief Summary

To evaluate patient characteristics in the current daily radiological practice of Gadovist application. Special focus will be laid on the individual risk factors of patients, the indications for and the dose of Gadovist application.

Secondary objective is to prove the known safety profile (especially rare adverse events) of Gadovist and to collect data on handling problems with different application forms (one questionnaire per center).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-31
• Study First Submitted QC: 2009-04-01
• Study First Posted: 2009-04-02
• Primary Completion: 2011-09
• Study Completion: 2011-11
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-19
• Last Update Posted: 2014-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3711

Inclusion Criteria

• patients with indication for a MRT or MR-Angiography and for whom the radiologist has decided to use the contrast medium Gadovist

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Exclusion Criteria

• No exclusion criteria besides the contraindications for the use of Gadovist as mentioned in the German product information.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Gadobutrol (Gadovist, BAY86-4875)	-

Primary Outcome Measures

Name	Time	Method
Patient Profile	At day of application

Secondary Outcome Measures

Name	Time	Method
Dosing of Gadovist in different indications	At time of application
Adverse Events	Throughout and after application