Trial Condition(s):

Diagnostic Imaging

Primovist post-marketing surveillance in Japan (PRIMOVIST)

Bayer Identifier:

15040

ClinicalTrials.gov Identifier:

NCT01411449

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

Inclusion Criteria
- Patients who received Primovist for liver MRI
Exclusion Criteria
- Patients who are contraindicated based on the product label

Trial Summary

Enrollment Goal
2030
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Eovist/Primovist (Gadoxetate disodium, BAY86-4873)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Japan

Status
Completed
 

Trial Design