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

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

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

Study Overview

• Status: Completed
• Conditions: Magnetic Resonance Imaging
• Intervention / Treatment: Drug: Gadobutrol (Gadovist, BAY86-4875)

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Philippines
  • Many Locations, Philippines

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients 18 years old and above who will undergo contrast enhanced MRI with Gadobutrol (Gadovist)

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1	Drug: Gadobutrol (Gadovist, BAY86-4875); Patients who will need to undergo contrast enhanced MRI with gadobutrol (Gadovist)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Up to 1 hour after MRI

Other Outcome Measures

Outcome Measure	Time Frame
Magnetic field strength of MRI	During the procedure
Volume of contrast agent used	During the procedure

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion: December 7, 2022
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: April 27, 2009
• First Submitted That Met QC Criteria: May 20, 2009
• First Posted (Estimate): May 21, 2009

Study Record Updates

• Last Update Posted (Estimate): April 26, 2013
• Last Update Submitted That Met QC Criteria: April 25, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Observational study; Magnetic Resonance Imaging (MRI); Gadobutrol
• Other Study ID Numbers: 13926; GV0811PH (Other Identifier: Company Internal)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No