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

Bayer

Status: Completed

Conditions: Magnetic Resonance Imaging

Treatments: Drug: Gadobutrol (Gadovist, BAY86-4875)

Study type: Observational

Funder types: Industry

Identifiers

NCT00905879

13926

GV0811PH (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

Group 1

Treatment:

Drug: Gadobutrol (Gadovist, BAY86-4875)