GARDIAN, Gadovist in Routine Diagnostic Magnetic Resonance Imaging Administration in Non-selected Patients

Bayer

Status: Completed

Conditions: Magnetic Resonance Angiography; Magnetic Resonance Imaging

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01095081

GV0901 (Other Identifier)

14823

Details and patient eligibility

About

Prospective, non-interventional, multi-center study. The observation period for each subject covers the treatment period with Gadovist®. For each patient, the treating physician or nurse documents demographics, medical data, safety parameters and treatment signs and symptoms at the visit. Patients with severe renal impairment will be followed-up after 3 month by phone call from the investigator if in line with routine practice. Data audit/monitoring by source data verification will be done in a subset of sites and patients

Full description

Evaluate the safety and tolerability of Gadovist in patients requiring contrast-enhanced MRI.

Enrollment: 23,775 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing contrast enhanced Magnetic Resonance Imaging with Gadobutrol (Gadovist).

Exclusion criteria

• There are no other exclusion criteria beyond the contraindications contained in the Summary of Product Characteristics (hypersensitivity to the active substance or to any of the excipients) and the warnings.

Trial design

23,775 participants in 1 patient group

Group 1

Treatment:

Drug: Gadobutrol (Gadovist, BAY86-4875)