Diagnostic Imaging
Conditions
Keywords
Primovist, MRI agent
Brief summary
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.
Interventions
Patients who will need to undergo contrast enhanced MRI with Primovist
Sponsors
Bayer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients who received Primovist for liver MRI
Exclusion criteria
* Patients who are contraindicated based on the product label
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse drug reactions and serious adverse events in subjects who received Primovist | After Primovist injection, up to 7 days |
| Incidence of adverse drug reactions in patients with renal impairment | After Primovist injection, up to 7 days |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, concomitant disease and dose of Primovist] | After Primovist injection, up to 7 days |
| MRI image evaluation assessment by the five rank scales of 1 to 5: 1) much improved; 2) improved; 3) slightly improved; 4) not improved; and 5) impaired | After Primovist injection, up to 7 days |
Countries
Japan
Outcome results
None listed