Observational Study on the Safety and Tolerability of Gadobutrol (Gadovist) Among Filipino Patients in Magnetic Resonance Imaging

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

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-01-31

Brief Summary

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Patients will be recruited from those who will undergo contrast enhanced MRI. Safety and tolerability will be assessed.

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Detailed Description

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Conditions

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Magnetic Resonance Imaging

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Gadobutrol (Gadovist, BAY86-4875)

Intervention Type DRUG

Patients who will need to undergo contrast enhanced MRI with gadobutrol (Gadovist)

Interventions

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Gadobutrol (Gadovist, BAY86-4875)

Patients who will need to undergo contrast enhanced MRI with gadobutrol (Gadovist)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 years old and above undergoing contrast enhanced cranial or spinal MRI with Gadobutrol (Gadovist)

Exclusion Criteria

* History of hypersensitivity reaction to gadolinium containing contrast material
* Hypersensitivity to any of the ingredients of Gadobutrol (Gadovist)
* History of hypersensitivity to any other contrast agent
* Patients with uncorrected hypokalemia
* Pregnant and lactating women
* Patients with severe cardiovascular diseases
* Patients in whom MRI cannot be performed.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No