Primovist Post-marketing Surveillance in Japan (PRIMOVIST)

Bayer

Status: Completed

Conditions: Diagnostic Imaging

Treatments: Drug: Gadoxetic Acid Disodium (Primovist, BAY86-4873)

Study type: Observational

Funder types: Industry

Identifiers

NCT01411449

15040

Details and patient eligibility

About

This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Primovist for contrast enhancement in MRI of liver. The objective of this study is to assess safety, especially in relation to renal dysfunction, and efficacy of using Primovist in clinical practice. A total 2,000 patients for diagnosis on detection and identify hepatic tumor will be recruited and followed 7 days after the injection.

Enrollment: 2,030 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who received Primovist for liver MRI

Exclusion criteria

• Patients who are contraindicated based on the product label

Trial design

2,030 participants in 1 patient group

Group 1

Treatment:

Drug: Gadoxetic Acid Disodium (Primovist, BAY86-4873)