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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Magnetic Resonance Imaging

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Philippines

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Gadobutrol (Gadovist, BAY86-4875)

Drug

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

Primary outcomes

The primary outcome measures would be safety and tolerability of Gadovist which would be measured by change in Vital signs before and after the procedure and the occurrence of serious or non-serious adverse events

Time frame: Up to 1 hour after MRI

Other outcomes

Magnetic field strength of MRI

Time frame: During the procedure
Volume of contrast agent used

Time frame: During the procedure

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Observational Study on the Safety and Tolerability of Gadobutrol (Gadovist) Among Filipino Patients

Important dates

Study start: 2009
Study completion: 2011
First posted: May 21, 2009
Registry last updated: Apr 26, 2013

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.

Published trials that share one or more normalized conditions with this study.

Completed